An interventional study of Inguinal lymph node fine needle aspirate biopsy and Inguinal lymph node core biopsy in Diabetes Mellitus, Type 1, sponsored by GlaxoSmithKline. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-27.
Sponsored by GlaxoSmithKline · Not applicable, Interventional, and Basic science
It is hypothesized that early changes in the immune system in New Onset Type 1 Diabetes Mellitus (NOT1D) subjects can be detected in immune cells from the inguinal lymph nodes (iLN), which will be distinct from changes observed in peripheral blood derived immune cells. Therefore this study will assess and compare the molecular immune profile of cells derived from the iLN in healthy and NOT1D subjects, to understand the immunological processes that may lead to beta cell destruction. It is a multi-center, non-drug treatment study. Up to 15 subjects in each group, namely healthy subjects and NOT1D subjects, will be evaluated in the study. A data look will be carried out after the recruitment of a cohort of up to 5 healthy subjects, to determine if the quality and quantity of cells derived from aspirate or core biopsy or from peripheral blood are likely to be sufficient to continue the study to meet its primary objective. An interim analysis will be carried out after the recruitment of 5 evaluable healthy subjects and 5 evaluable NOT1D subjects. The primary purpose of this interim analysis will be to facilitate decision making and study design for a potential follow-up interventional study.
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Exclusion Criteria:
Up to 30 mL of blood sample will be collected from healthy subjects. Inguinal lymph node fine needle aspirate biopsy and core biopsy will be performed. Leukocyte subset phenotyping will be carried out on iLN-derived cells by assessing expression of (but not restricted to) the following antigens: CD3, CD4, CD8, CD11c, CD14, CD16, CD19, CD24, CD25, CD38, CD45RA, CD56, Human Leukocyte antigen D related (HLA-DR) and forkhead box P3 protein also called scurfin (FOXP3).
Procedure: Inguinal lymph node fine needle aspirate biopsy · Procedure: Inguinal lymph node core biopsy · Procedure: Peripheral blood collection · Other: Pre- and post-biopsy questionnaire
Up to 30 mL of blood sample will be collected from subjects with NOT1D. Inguinal lymph node fine needle aspirate biopsy and core biopsy will be performed. Leukocyte subset phenotyping will be carried out on iLN-derived cells by assessing expression of (but not restricted to) the following antigens: CD3, CD4, CD8, CD11c, CD14, CD16, CD19, CD24, CD25, CD38, CD45RA, CD56, HLA-DR and FOXP3.
Procedure: Inguinal lymph node fine needle aspirate biopsy · Procedure: Inguinal lymph node core biopsy · Procedure: Peripheral blood collection · Other: Pre- and post-biopsy questionnaire
Inguinal lymph node will be localized by ultrasonography and sampled by 21-gauge needle and a 5 mL syringe using to and fro needle movement while applying 1 mL suction with the syringe. Up to 2 fine needle aspirate passages will be obtained, to derive immune cells.
Inguinal lymph node will be localized by ultrasonography and following fine needle aspirate, an incision will be made. Up to five core biopsies will be obtained, to derive immune cells.
Blood sample (30 mL) will be collected, to derive immune cells.
All subjects will be asked to complete a questionnaire about their expectations/experiences of undergoing the biopsy procedures.
Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in Blood
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. The analysis was based upon Safety Population which comprised of all participants who complete any study assessment. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.
Time frame: Pre Biopsy session on Day 1
Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.
Time frame: Biopsy session on Day 1
Percentage of Leukocyte Subsets Including B-cells, Clusters of Differentiation 56 Positive (CD56+) CD16+ , CD56bright Natural Killer (NK) Cells, CD56lo CD16+, CD56lo CD16 Negative (CD56lo CD16-), Dendritic Cells, NK Cells in Blood
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. NA indicates that data was not available.
Time frame: Pre Biopsy session on Day 1
Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16-, Dendritic Cells, NK Cells in iLN
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.
Time frame: Biopsy session on Day 1
Percentage of Leukocyte Subsets Including CD56+CD16+, CD56bright NK Cells, CD56lo CD16+ and CD56lo CD16- in Blood
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. NA indicates that data was not available.
Time frame: Pre Biopsy session on Day 1
Percentage of Leukocyte Subsets Including CD56+CD16+, CD56bright NK Cells CD56lo CD16+ and CD56lo CD16- in iLN
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.
Time frame: Biopsy session on Day 1
Percentage of Leukocyte Subsets Including Myeloid Dendritic Cells and Plasmacytoid Dendritic Cells in Blood
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.
Time frame: Pre Biopsy session on Day 1
Percentage of Leukocyte Subsets Including Myeloid Dendritic Cells and Plasmacytoid Dendritic Cells in iLN
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
Time frame: Biopsy session on Day 1
Percentage of Leukocyte Subsets Including CD14+ CD16+ Monocytes, CD14+ Monocytes, and CD16+ Monocytes in Blood
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. NA indicates that data was not available.
Time frame: Pre Biopsy session on Day 1
Percentage of Leukocyte Subsets Including CD14+ CD16+ Monocytes, CD14+ Monocytes and CD16+ Monocytes in iLN
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.
Time frame: Biopsy session on Day 1
Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 Cells in Blood
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.
Time frame: Pre Biopsy session on Day 1
Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 Cells in iLN
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.
Time frame: Biopsy session on Day 1
Percentage of Leukocyte Subsets Including Programmed Death 1 (PD-1)+ Inducible Costimulator (ICOS)+ Follicular Helper T (TFH) Cell-like Regulatory (Reg) T Cells in Blood
Peripheral blood samples were planned to be collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Results could not be presented as data were not collected for this analysis due to lack of model convergence or model reliability
Time frame: Pre Biopsy session on Day 1
Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cell-like Reg T Cells in iLN
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. NA indicates that data was not available.
Time frame: Biopsy session on Day 1
Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cells in Blood
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.
Time frame: Pre Biopsy session on Day 1
Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cells in iLN
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.
Time frame: Biopsy session on Day 1
Percentage of Leukocyte Subsets Including Central Memory Conventional (Conv) T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in Blood
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.
Time frame: Pre Biopsy session on Day 1
Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.
Time frame: Biopsy session on Day 1
Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in Blood
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
Time frame: Pre Biopsy session on Day 1
Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
Time frame: Biopsy session on Day 1
Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in Blood
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. NA indicates that data was not availble. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
Time frame: Pre Biopsy session on Day 1
Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.
Time frame: Biopsy session on Day 1
Percentage of Leukocyte Subsets Including Reg T Cells in Blood
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.
Time frame: Pre Biopsy session on Day 1
Percentage of Leukocyte Subsets Including Reg T Cells in iLN
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.
Time frame: Biopsy session on Day 1
Percentage of Leukocyte Subsets Including CD69+ CD8 and Antigen Ki67 (Ki67)+ CD8 in Blood
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.
Time frame: Pre Biopsy session on Day 1
Percentage of Leukocyte Subsets Including CD69+ CD8 and Antigen Ki67 (Ki67)+ CD8 in iLN
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
Time frame: Biopsy session on Day 1
Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in Blood
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
Time frame: Pre Biopsy session on Day 1
Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
Time frame: Biopsy session on Day 1
Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in Blood
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.
Time frame: Pre Biopsy session on Day 1
Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in iLN
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
Time frame: Biopsy session on Day 1
Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in Blood
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.
Time frame: Pre Biopsy session on Day 1
Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in iLN
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
Time frame: Biopsy session on Day 1
Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN Core Biopsies and iLN FNA
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.
Time frame: Biopsy session on Day 1
Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16, Dendritic Cells, NK Cells in iLN Core Biopsies and iLN FNA
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.
Time frame: Biopsy session on Day 1
Percentage of Leukocyte Subsets Including CD56+CD16+, CD56br NK Cells CD56lo CD16+ and CD56lo CD16- in iLN Core Biopsies and iLN FNA
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.
Time frame: Biopsy session on Day 1
Percentage of Leukocyte Subsets Including Myeloid Dendritic Cells and Plasmacytoid Dendritic Cells in iLN Core Biopsies and iLN FNA
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
Time frame: Biopsy session on Day 1
Percentage of Leukocyte Subsets Including CD14+ CD16+ Monocytes, CD14+ Monocytes and CD16+ Monocytes in iLN Core Biopsies and iLN FNA
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates data was not available.
Time frame: Biopsy session on Day 1
Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 in iLN Core Biopsies and iLN FNA
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
Time frame: Biopsy session on Day 1
Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cell-like Reg T Cells in iLN Core Biopsies and iLN FNA
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.
Time frame: Biopsy session on Day 1
Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cells in iLN Core Biopsies and iLN FNA
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
Time frame: Biopsy session on Day 1
Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN Core Biopsies and iLN FNA
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
Time frame: Biopsy session on Day 1
Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
Time frame: Biopsy session on Day 1
Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN Core Biopsies and iLN FNA
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.
Time frame: Biopsy session on Day 1
Percentage of Leukocyte Subsets Including Reg T Cells in iLN Core Biopsies and iLN FNA
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
Time frame: Biopsy session on Day 1
Percentage of Leukocyte Subsets Including CD69+ CD8 and Antigen Ki67 (Ki67)+ CD8 in iLN Core Biopsies and iLN FNA
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
Time frame: Biopsy session on Day 1
Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN Core Biopsies and iLN FNA
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
Time frame: Biopsy session on Day 1
Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in iLN Core Biopsies and iLN FNA
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
Time frame: Biopsy session on Day 1
Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in iLN Core Biopsies and iLN FNA
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
Time frame: Biopsy session on Day 1
Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/ incapacity, is a congenital anomaly/ birth defect or other situations.
Time frame: Up to Day 14
Number of Participants Undergoing Procedure Under Local Anesthetics
Participants were asked to complete Pre-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The number of participants who underwent procedure under local anesthetics have been presented.
Time frame: Up to Day 4
Number of Participants Undergoing iLN Biopsy Under Local Anesthetics
Participants were asked to complete Pre-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The number of participants who underwent iLN biopsy under local anesthetics have been presented.
Time frame: Up to Day 4
Number of Participants With Different Reasons for Participating in the Study
Participants were asked to complete Pre-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The different reasons have been listed as follows; have friend with diabetes mellitus (DM)/ to progress knowledge, to improve medicines development, participating in the study because of the honorarium, any other reason not listed above was categorized as "other" and participants having all three reasons as listed above to participate in the study were included in "All reasons" category
Time frame: Up to Day 4
Number of Participants With Extreme Anxiety Towards the Lymph Node Biopsy
Participants were asked to complete Pre-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The number of participants with extreme anxiety towards the procedure have been presented.
Time frame: Up to Day 4
Number of Participants Looking Forward to Undergo the Procedure
Participants were asked to complete Pre-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The number of participants looking forward to undergo the procedure have been presented.
Time frame: Up to Day 4
Number of Participants With Aspects Better Explained About the Lymph Node Biopsy Procedure
Participants were asked to complete Post-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The aspects better explained were as follows; itself, anesthetic procedure, after-care, none and any other procedure not listed above was categorized as "other".
Time frame: Up to Day 4
Number of Participants Who Considered to Undergo Lymph Node Biopsy Procedure Another Time
Participants were asked to complete Post-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The number of participants who considered to undergo procedure another time have been presented.
Time frame: Up to Day 4
Number of Participants Who Were Encouraged to be Included in Study for iLN Biopsy
Participants were asked to complete Post-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. Participants who were encouraged in study for iLN biopsy have been presented.
Time frame: Up to Day 4
Number of Participants Who Appreciated Receiving Study Feedback
Participants were asked to complete Post-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. Participants who appreciated receiving study feedback have been presented.
Time frame: Up to Day 4
This was a multi-center, non-drug treatment study to compare differences in immune cells derived from the inguinal lymph nodes (iLN) and peripheral blood of New Onset Type 1 Diabetes Mellitus (NOT1D) participants and healthy volunteers. Participants were enrolled at a single center in United Kingdom.
| Milestone | Healthy Participants | Participants With NOT1D |
|---|---|---|
| Started | 12 | 10 |
| Completed | 12 | 10 |
| Not completed | 0 | 0 |
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. The analysis was based upon Safety Population which comprised of all participants who complete any study assessment. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.
| Percentage of B lymphocytes | Healthy Participants | Participants With NOT1D |
|---|---|---|
| Circulating B Lymphocytes; n=12, 10 | 16.54 ± 2.229 | 14.23 ± 2.442 |
| Classical B Lymphocytes; n=12, 10 | 19.37 ± 1.616 | 15.83 ± 1.771 |
| Double Negative B Lymphocytes; n=12, 10 | 3.25 ± 1.250 | 6.26 ± 1.370 |
| Naive B Lymphocytes; n=12, 10 | 59.81 ± 3.021 | 62.32 ± 3.310 |
| Plasmablast ; n=11, 10 | NA ± NA | NA ± NA |
| Transitional B Lymphocytes; n=12, 10 | NA ± NA | NA ± NA |
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.
| Percentage of B lymphocytes | Healthy Participants | Participants With NOT1D |
|---|---|---|
| Circulating B Lymphocytes; n=9, 10 | 15.51 ± 1.860 | 12.14 ± 1.898 |
| Classical B Lymphocytes; n=9, 10 | 38.78 ± 4.119 | 30.19 ± 4.130 |
| Double Negative B Lymphocytes; n=9, 10 | 8.68 ± 1.668 | 10.26 ± 1.651 |
| Naive B Lymphocytes; n=9, 10 | 35.83 ± 3.761 | 44.13 ± 3.621 |
| Plasmablast; n=4, 8 | NA ± NA | NA ± NA |
| Transitional B Lymphocytes; ; n=3, 2 | NA ± NA | NA ± NA |
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. NA indicates that data was not available.
| Percentage of mononuclear cells | Healthy Participants | Participants With NOT1D |
|---|---|---|
| B-cells | 8.50 ± 0.589 | 7.58 ± 0.645 |
| CD56+CD16+ | NA ± NA | NA ± NA |
| CD56bright NK cells | 0.36 ± 0.042 | 0.30 ± 0.046 |
| CD56lo CD16+ | 7.96 ± 1.011 | 8.24 ± 1.108 |
| CD56lo CD16- | 0.24 ± 0.036 | 0.23 ± 0.040 |
| Dendritic cells | 0.93 ± 0.080 | 0.87 ± 0.088 |
| NK cells | 8.71 ± 0.999 | 8.84 ± 1.095 |
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.
| Percentage of mononuclear cells | Healthy Participants | Participants With NOT1D |
|---|---|---|
| B-cells; n=9, 10 | 8.88 ± 1.641 | 7.34 ± 1.512 |
| CD56+CD16+; n=8, 8 | NA ± NA | NA ± NA |
| CD56bright NK cells; n=9, 10 | 0.54 ± 0.098 | 0.50 ± 0.101 |
| CD56lo CD16+; n=9, 10 | 0.68 ± 0.173 | 0.69 ± 0.184 |
| CD56lo CD16-; n=8, 9 | 0.19 ± 0.043 | 0.21 ± 0.040 |
| Dendritic cells; n=9, 10 | 0.45 ± 0.100 | 0.39 ± 0.081 |
| NK cells; n=9, 10 | 1.43 ± 0.324 | 1.50 ± 0.364 |
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. NA indicates that data was not available.
| Percentage of NK cells | Healthy Participants | Participants With NOT1D |
|---|---|---|
| CD56+CD16+ | NA ± NA | NA ± NA |
| CD56bright NK cells | 5.02 ± 0.894 | 3.99 ± 0.980 |
| CD56lo CD16+ | 89.71 ± 1.567 | 92.40 ± 1.717 |
| CD56lo CD16- | 3.11 ± 0.497 | 2.70 ± 0.545 |
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.
| Percentage of NK cells | Healthy Participants | Participants With NOT1D |
|---|---|---|
| CD56+CD16+; n=8, 8 | NA ± NA | NA ± NA |
| CD56bright NK cells; n=9, 10 | 41.85 ± 3.999 | 35.01 ± 3.868 |
| CD56lo CD16+; n=9, 10 | 37.12 ± 6.220 | 45.01 ± 4.900 |
| CD56lo CD16-; n=8, 9 | 12.80 ± 1.855 | 14.26 ± 1.490 |
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.
| Percentage of total dendritic cells | Healthy Participants | Participants With NOT1D |
|---|---|---|
| Myeloid Dendritic cells | 51.78 ± 3.073 | 50.45 ± 3.366 |
| Plasmacytoid Dendritic cells | 45.51 ± 3.140 | 47.36 ± 3.440 |
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
| Percentage of total dendritic cells | Healthy Participants | Participants With NOT1D |
|---|---|---|
| Myeloid Dendritic cells; n=8, 10 | 42.96 ± 3.870 | 30.72 ± 4.128 |
| Plasmacytoid Dendritic cells; n=9, 9 | 57.43 ± 4.426 | 68.30 ± 5.372 |
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. NA indicates that data was not available.
| Percentage of monocytes | Healthy Participants | Participants With NOT1D |
|---|---|---|
| CD14+ CD16+ monocytes | NA ± NA | NA ± NA |
| CD14+ monocytes | NA ± NA | NA ± NA |
| CD16+ monocytes | NA ± NA | NA ± NA |
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.
| Percentage of monocytes | Healthy Participants | Participants With NOT1D |
|---|---|---|
| CD14+ CD16+ monocytes; n=0, 1 | — | NA ± NA |
| CD14+ monocytes; n=7, 4 | NA ± NA | NA ± NA |
| CD16+ monocytes; n=0, 2 | — | NA ± NA |
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.
| Percentage of CD8 T cells | Healthy Participants | Participants With NOT1D |
|---|---|---|
| CD45RA+ Effector Memory CD8 | 29.89 ± 4.267 | 28.10 ± 4.674 |
| Central Memory CD8 | 7.13 ± 1.537 | 6.98 ± 1.684 |
| Effector Memory CD8 | 19.22 ± 2.223 | 14.84 ± 2.435 |
| Naive CD8 | 34.38 ± 3.863 | 40.44 ± 4.231 |
| Stem Cell Memory-like CD8 | 1.34 ± 0.206 | 1.37 ± 0.225 |
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.
| Percentage of CD8 T cells | Healthy Participants | Participants With NOT1D |
|---|---|---|
| CD45RA+ Effector Memory CD8 | 14.54 ± 2.094 | 13.34 ± 2.330 |
| Central Memory CD8 | 5.55 ± 0.978 | 6.21 ± 1.093 |
| Effector Memory CD8 | 13.74 ± 1.867 | 15.59 ± 2.074 |
| Naive CD8 | 55.12 ± 4.259 | 54.45 ± 4.700 |
| Stem Cell Memory-like CD8 | 1.69 ± 0.316 | 2.36 ± 0.377 |
Peripheral blood samples were planned to be collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Results could not be presented as data were not collected for this analysis due to lack of model convergence or model reliability
No measurements were reported for this outcome.
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. NA indicates that data was not available.
| Percentage of TFH cell-like Reg T cells | Healthy Participants | Participants With NOT1D |
|---|---|---|
| Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cell-like Reg T Cells in iLN | NA ± NA | NA ± NA |
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.
| Percentage of TFH cells | Healthy Participants | Participants With NOT1D |
|---|---|---|
| Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cells in Blood | 0.53 ± 0.173 | 0.87 ± 0.160 |
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.
| Percentage of TFH cells | Healthy Participants | Participants With NOT1D |
|---|---|---|
| Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cells in iLN | 2.75 ± 3.192 | 8.96 ± 2.973 |
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.
| Percentage of total Conv T cells | Healthy Participants | Participants With NOT1D |
|---|---|---|
| CD45RA+ Effector Memory Conv T cells | 2.47 ± 0.856 | 1.44 ± 0.937 |
| Central Memory Conv T cells | 32.21 ± 2.125 | 33.75 ± 2.328 |
| Effector Memory Conv T cells | 11.74 ± 1.409 | 11.97 ± 1.543 |
| Naive Conv T cells | 43.40 ± 2.586 | 42.48 ± 2.833 |
| Stem Cell Memory-like Conv T cells | 0.91 ± 0.098 | 1.01 ± 0.107 |
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.
| Percentage of total Conv T cells | Healthy Participants | Participants With NOT1D |
|---|---|---|
| CD45RA+ Effector Memory Conv T cells | 1.14 ± 0.152 | 0.88 ± 0.180 |
| Central Memory Conv T cells | 23.07 ± 2.646 | 25.03 ± 2.923 |
| Effector Memory Conv T cells | 20.43 ± 2.422 | 18.28 ± 2.692 |
| Naive Conv T cells | 46.13 ± 3.081 | 46.93 ± 3.454 |
| Stem Cell Memory-like Conv T cells | 1.35 ± 0.176 | 1.57 ± 0.201 |
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
| Percentage of total memory Conv T cells | Healthy Participants | Participants With NOT1D |
|---|---|---|
| TFH cells; n=12, 10 | 16.77 ± 1.723 | 21.86 ± 1.888 |
| PD-1+ ICOS+ TFH cells; n=6, 7 | 0.13 ± 0.036 | 0.18 ± 0.035 |
| TH17 cells; n=12, 10 | 7.79 ± 0.963 | 7.89 ± 1.055 |
| TH1 cells; n=12, 10 | 19.69 ± 2.895 | 17.60 ± 3.172 |
| TH1 TH17 cells; n=12, 10 | 16.25 ± 1.606 | 16.22 ± 1.759 |
| TH1 TH17 TH2 T cells; n=12, 10 | 7.16 ± 0.750 | 7.16 ± 0.821 |
| TH1 TH2 cells; n=12, 10 | 9.30 ± 0.692 | 9.90 ± 0.758 |
| TH2 cells; n=12, 10 | 8.46 ± 0.994 | 6.89 ± 1.089 |
| TH22 cells; n=12, 10 | 3.00 ± 0.340 | 3.01 ± 0.372 |
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
| Percenatge of total memory Conv T cells | Healthy Participants | Participants With NOT1D |
|---|---|---|
| TFH cells; n=12,10 | 23.02 ± 2.385 | 21.48 ± 2.706 |
| PD-1+ ICOS+ TFH cells; n=10,10 | 1.30 ± 0.662 | 1.93 ± 0.542 |
| TH17 cells; n=12,10 | 6.56 ± 0.932 | 6.15 ± 1.033 |
| TH1 cells; n=12,10 | 15.08 ± 1.878 | 18.58 ± 2.110 |
| TH1 TH17 cells; n=11,10 | 3.03 ± 0.483 | 2.78 ± 0.558 |
| TH1 TH17 TH2 T cells; n=11,10 | 1.94 ± 0.360 | 1.54 ± 0.409 |
| TH1 TH2 cells; n=12,10 | 7.73 ± 0.816 | 7.25 ± 0.942 |
| TH2 cells; n=12,10 | 20.03 ± 1.754 | 16.98 ± 1.975 |
| TH22 cells; n=12,10 | 1.50 ± 0.277 | 1.48 ± 0.352 |
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. NA indicates that data was not availble. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
| Percentage of total memory Reg T cells | Healthy Participants | Participants With NOT1D |
|---|---|---|
| TFH cells-like Reg T cells; n=12, 10 | 11.63 ± 1.901 | 16.46 ± 2.083 |
| TH1 cells-like Reg T cells; n=12, 10 | 5.35 ± 0.643 | 6.18 ± 0.704 |
| TH1 TH17-like Reg T cells; n=7, 7 | NA ± NA | NA ± NA |
| TH1 TH17 TH2 cells-like Reg T cells; n=12, 10 | 10.48 ± 1.036 | 13.36 ± 1.135 |
| TH1 TH2 cells-like Reg T cells; n=12, 10 | 12.04 ± 0.649 | 10.24 ± 0.711 |
| TH17 cells-like Reg T cells; n=12, 10 | 17.37 ± 0.869 | 17.67 ± 0.952 |
| TH2 cells-like Reg T cells; n=12, 10 | 12.47 ± 1.285 | 9.09 ± 1.408 |
| TH22 cells-like Reg T cells; n=12, 10 | 11.46 ± 0.953 | 12.63 ± 1.044 |
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.
| Percentage of total memory Reg T cells | Healthy Participants | Participants With NOT1D |
|---|---|---|
| TFH cells-like Reg T cells; n=12, 10 | 13.48 ± 1.913 | 12.97 ± 2.203 |
| PD-1+ ICOS+ TFH cells-like Reg T cells; n=5,7 | NA ± NA | NA ± NA |
| TH1 cells-like Reg T cells; n=12, 10 | 7.31 ± 1.202 | 11.41 ± 1.395 |
| TH1 TH17-like Reg T cells; n=1, 2 | NA ± NA | NA ± NA |
| TH1 TH17 TH2 cells-like Reg T cells; n=7, 6 | 2.56 ± 0.839 | 4.11 ± 0.871 |
| TH1 TH2 cells-like Reg T cells; n=12, 10 | 10.12 ± 1.085 | 10.99 ± 1.342 |
| TH17 cells-like Reg T cells; n=12, 10 | 7.20 ± 1.418 | 7.67 ± 1.673 |
| TH2 cells-like Reg T cells; n=12, 10 | 27.83 ± 2.262 | 27.24 ± 2.546 |
| TH22 cells-like Reg T cells; n=8, 7 | 2.29 ± 0.513 | 2.70 ± 0.628 |
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.
| Percentage of CD4 T cells | Healthy Participants | Participants With NOT1D |
|---|---|---|
| Percentage of Leukocyte Subsets Including Reg T Cells in Blood | 6.95 ± 0.405 | 6.56 ± 0.444 |
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.
| Percentage of CD4 T cells | Healthy Participants | Participants With NOT1D |
|---|---|---|
| Percentage of Leukocyte Subsets Including Reg T Cells in iLN | 12.04 ± 0.631 | 12.28 ± 0.682 |
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.
| Percentage of CD8 T cells | Healthy Participants | Participants With NOT1D |
|---|---|---|
| CD69+ CD8 cells | 3.23 ± 0.299 | 2.28 ± 0.327 |
| Ki67+ CD8 cells | 1.06 ± 0.391 | 1.89 ± 0.429 |
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
| Percentage of CD8 T cells | Healthy Participants | Participants With NOT1D |
|---|---|---|
| CD69+ CD8 cells; n=11, 9 | 17.77 ± 2.950 | 20.54 ± 3.127 |
| Ki67+ CD8 cells; n= 11, 6 | 5.86 ± 0.646 | 3.66 ± 0.828 |
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
| Percentage of T Reg cells | Healthy Participants | Participants With NOT1D |
|---|---|---|
| CD15s+ Reg T cells; n= 12, 10 | 7.84 ± 1.492 | 9.13 ± 1.635 |
| CD69+ Reg T cells; n= 11, 10 | 3.19 ± 0.213 | 2.27 ± 0.223 |
| Helios+ Reg T cells; n= 12, 10 | 75.19 ± 2.034 | 70.98 ± 2.228 |
| Ki67+ T Reg cells; n= 12, 10 | 5.34 ± 0.664 | 6.32 ± 0.727 |
| Memory Reg T cells; n= 12, 10 | 40.93 ± 2.563 | 45.79 ± 2.808 |
| Resting Reg T cells n= 12, 10 | 45.34 ± 3.191 | 36.74 ± 3.496 |
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
| Percentage of T Reg cells | Healthy Participants | Participants With NOT1D |
|---|---|---|
| CD15s+ Reg T cells; n=11, 8 | 16.54 ± 3.248 | 10.01 ± 3.675 |
| CD69+ Reg T cells; n= 11, 9 | 48.02 ± 3.034 | 56.55 ± 3.451 |
| Helios+ Reg T cells; n=11,9 | 81.28 ± 1.723 | 79.17 ± 1.837 |
| Ki67+ T Reg cell; n= 10, 8 | 8.39 ± 1.347 | 5.09 ± 1.505 |
| Memory Reg T cells; n= 11, 9 | 50.12 ± 2.660 | 49.90 ± 3.022 |
| Resting Reg T cells; n=11,9 | 35.32 ± 3.031 | 27.00 ± 3.453 |
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.
| Percentage of total Conv T cells | Healthy Participants | Participants With NOT1D |
|---|---|---|
| CD15s+ Conv T cells | 2.59 ± 0.405 | 2.28 ± 0.444 |
| CD69+ Conv T cells | 2.05 ± 0.206 | 1.41 ± 0.226 |
| Helios+ Conv T cells | 2.07 ± 0.233 | 1.68 ± 0.255 |
| Ki67+ Conv T cells | 1.02 ± 0.202 | 1.18 ± 0.221 |
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
| Percentage of total Conv T cells | Healthy Participants | Participants With NOT1D |
|---|---|---|
| CD15s+ Conv T cells; n=11, 8 | 4.43 ± 0.653 | 2.65 ± 0.743 |
| CD69+ Conv T cells; n=11, 9 | 27.74 ± 3.060 | 30.29 ± 3.589 |
| Helios+ Conv T cells;n=11,9 | 5.50 ± 0.631 | 5.35 ± 0.720 |
| Ki67+ Conv T cells; n= 11,8 | 4.39 ± 0.560 | 1.65 ± 0.669 |
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.
| Percentage of total memory Conv T cells | Healthy Participants | Participants With NOT1D |
|---|---|---|
| CD15s+ Memory Conv T cells | 5.39 ± 0.906 | 4.82 ± 0.993 |
| CD69+ Memory Conv T cells | 2.53 ± 0.237 | 1.69 ± 0.259 |
| Helios+ Memory Conv T cells | 3.46 ± 0.401 | 2.64 ± 0.439 |
| Ki67+ Memory Conv T cells | 2.03 ± 0.397 | 2.34 ± 0.435 |
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
| Percentage of total memory Conv T cells | Healthy Participants | Participants With NOT1D |
|---|---|---|
| CD15s+ Memory Conv T cells; n=11, 8 | 7.60 ± 1.131 | 4.59 ± 1.307 |
| CD69+ Memory Conv T cells; n=11, 9 | 44.32 ± 2.739 | 46.38 ± 3.433 |
| Helios+ Memory Conv T cells; n= 11, 9 | 8.25 ± 1.450 | 6.97 ± 1.438 |
| Ki67+ Memory Conv T cells; n=11,8 | 4.47 ± 0.545 | 2.33 ± 0.643 |
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.
| Percentage of B lymphocytes | Healthy Participants | Participants With NOT1D |
|---|---|---|
| Circulating B Lymphocytes; FNA; n=9,4 | 14.36 ± 2.104 | 12.07 ± 2.272 |
| Circulating B Lymphocytes; Core; n=4, 8 | 16.66 ± 1.668 | 12.20 ± 1.633 |
| Classical B Lymphocytes; FNA; n=9,4 | 39.89 ± 4.438 | 28.35 ± 6.283 |
| Classical B Lymphocytes; Core; n= 4, 8 | 37.66 ± 4.711 | 32.02 ± 3.716 |
| Double Negative B Lymphocytes; FNA; n=9,4 | 8.48 ± 2.285 | 9.85 ± 2.430 |
| Double Negative B Lymphocytes; Core; n= 4, 8 | 8.89 ± 1.302 | 10.68 ± 1.177 |
| Naive B Lymphocytes;FNA; n=9,4 | 36.05 ± 3.545 | 44.36 ± 4.939 |
| Naive B Lymphocytes; Core; n= 4, 8 | 35.60 ± 4.671 | 43.91 ± 3.796 |
| Plasmablast; FNA; n=4, 3 | NA ± NA | NA ± NA |
| Plasmablast; Core; n=0, 5 | — | NA ± NA |
| Transitional B Lymphocytes; FNA; n=2, 1 | NA ± NA | NA ± NA |
| Transitional B Lymphocytes;Core; n=1, 2 | NA ± NA | NA ± NA |
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.
| Percentage of mononuclear cells | Healthy Participants | Participants With NOT1D |
|---|---|---|
| B-cells; FNA; n=9, 4 | 10.48 ± 1.417 | 5.51 ± 2.106 |
| B-cells; Core; n=4, 8 | 7.29 ± 2.411 | 9.17 ± 1.769 |
| CD56+CD16+; FNA; n=8, 2 | NA ± NA | NA ± NA |
| CD56+CD16+; Core; n=2, 7 | NA ± NA | NA ± NA |
| CD56bright NK cells; FNA; n=9, 4 | 0.61 ± 0.110 | 0.47 ± 0.154 |
| CD56bright NK cells; Core; n=4, 8 | 0.47 ± 0.118 | 0.53 ± 0.089 |
| CD56lo CD16+; FNA; n=9, 4 | 0.55 ± 0.215 | 0.94 ± 0.340 |
| CD56lo CD16+; Core; n=3, 8 | 0.82 ± 0.272 | 0.45 ± 0.152 |
| CD56lo CD16-; FNA; n=8, 4 | 0.19 ± 0.042 | 0.21 ± 0.053 |
| CD56lo CD16-; Core; n=3,7 | 0.18 ± 0.054 | 0.21 ± 0.041 |
| Dendritic cells; FNA; n=9, 4 | 0.47 ± 0.061 | 0.24 ± 0.097 |
| Dendritic cells; Core; n=4, 8 | 0.44 ± 0.183 | 0.54 ± 0.125 |
| NK cells; FNA; n=9, 4 | 1.60 ± 0.425 | 1.66 ± 0.637 |
| NK cells; Core; n=4, 8 | 1.27 ± 0.333 | 1.35 ± 0.251 |
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.
| Percentage of NK cells | Healthy Participants | Participants With NOT1D |
|---|---|---|
| CD56+CD16+; FNA; n=8, 2 | NA ± NA | NA ± NA |
| CD56+CD16+; Core; n=2, 7 | NA ± NA | NA ± NA |
| CD56bright NK cells; FNA; n=9, 4 | 40.37 ± 3.934 | 26.65 ± 6.356 |
| CD56bright NK cells; Core; n=4, 8 | 43.32 ± 6.340 | 43.36 ± 4.129 |
| CD56lo CD16+; FNA; n=9, 4 | 34.66 ± 4.476 | 54.69 ± 7.327 |
| CD56lo CD16+; Core; n=3, 8 | 39.58 ± 11.072 | 35.32 ± 6.300 |
| CD56lo CD16-; FNA; n=8, 4 | 13.17 ± 1.321 | 13.31 ± 2.039 |
| CD56lo CD16-; Core; n=3, 7 | 12.42 ± 3.479 | 15.21 ± 2.258 |
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
| Percentage of total dendritic cells | Healthy Participants | Participants With NOT1D |
|---|---|---|
| Myeloid Dendritic cells; FNA; n=8, 4 | 46.76 ± 4.383 | 38.50 ± 6.298 |
| Myeloid Dendritic cells; Core; n=4 ,8 | 39.16 ± 4.626 | 22.95 ± 4.111 |
| Plasmacytoid Dendritic cells; FNA; n=9, 3 | 54.59 ± 5.834 | 62.48 ± 8.742 |
| Plasmacytoid Dendritic cells; Core; n=4, 8 | 60.27 ± 4.185 | 74.12 ± 3.988 |
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates data was not available.
| Percentage of monocytes | Healthy Participants | Participants With NOT1D |
|---|---|---|
| CD14+ CD16+ monocytes; ;FNA; n=0, 1 | — | NA ± NA |
| CD14+ monocytes; ;FNA; n=5, 2 | NA ± NA | NA ± NA |
| CD14+ monocytes;Core; n=3, 3 | NA ± NA | NA ± NA |
| CD16+ monocytes; ;FNA; n=0, 2 | — | NA ± NA |
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
| Percentage of CD8 T cells | Healthy Participants | Participants With NOT1D |
|---|---|---|
| CD45RA+ Effector Memory CD8; FNA; n=12, 8 | 11.96 ± 2.298 | 13.58 ± 2.721 |
| CD45RA+ Effector Memory CD8; Core; n=11, 10 | 17.12 ± 2.342 | 13.11 ± 2.489 |
| Central Memory CD8; FNA; n=12, 7 | 4.84 ± 0.895 | 5.00 ± 1.113 |
| Central Memory CD8; Core; n=11, 10 | 6.25 ± 1.264 | 7.41 ± 1.352 |
| Effector Memory CD8; FNA; n=12, 8 | 11.32 ± 2.026 | 13.43 ± 2.389 |
| Effector Memory CD8; Core; n= 11, 10 | 16.16 ± 2.105 | 17.76 ± 2.236 |
| Naive CD8; FNA; n=12, 8 | 61.17 ± 4.306 | 57.65 ± 4.994 |
| Naive CD8; Core; n=11, 10 | 49.07 ± 4.888 | 51.25 ± 5.224 |
| Stem Cell Memory-like CD8;FNA; n= 12, 6 | 1.73 ± 0.428 | 2.65 ± 0.563 |
| Stem Cell Memory-like CD8; Core; 9,10 | 1.64 ± 0.257 | 2.06 ± 0.269 |
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.
| Percentage of TFH cell-like Reg T Cells | Healthy Participants | Participants With NOT1D |
|---|---|---|
| PD-1+ ICOS+ TFH cell-like Reg T cells; FNA;n=2, 3 | NA ± NA | NA ± NA |
| PD-1+ ICOS+ TFH cell-like Reg T cells; Core; n=4,5 | NA ± NA | NA ± NA |
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
| Percentage of TFH cells | Healthy Participants | Participants With NOT1D |
|---|---|---|
| PD-1+ ICOS+ TFH cells; FNA; n=8, 4 | 3.95 ± 1.601 | 9.34 ± 1.977 |
| PD-1+ ICOS+ TFH cells; Core; n=6, 10 | 1.55 ± 5.416 | 8.58 ± 4.613 |
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
| Percentage of total Conv T cell | Healthy Participants | Participants With NOT1D |
|---|---|---|
| CD45RA+ Effector Memory Conv T cells; FNA; n=12, 7 | 1.16 ± 0.221 | 0.77 ± 0.282 |
| CD45RA+ Effector Memory Conv T cells;Core;n=11, 10 | 1.13 ± 0.126 | 0.99 ± 0.133 |
| Central Memory Conv T cells; FNA; n= 12, 8 | 21.15 ± 2.765 | 21.34 ± 3.188 |
| Central Memory Conv T cells; Core; n= 11, 10 | 24.99 ± 2.881 | 28.71 ± 3.087 |
| Effector Memory Conv T cells; FNA; n=12, 8 | 17.71 ± 2.605 | 15.46 ± 3.080 |
| Effector Memory Conv T cells; Core; n=11, 10 | 23.16 ± 2.736 | 21.10 ± 2.909 |
| Naive Conv T cells; FNA; n=12,8 | 50.43 ± 3.672 | 52.52 ± 4.395 |
| Naive Conv T cells; Core; n=11, 10 | 41.82 ± 3.421 | 41.34 ± 3.614 |
| Stem Cell Memory-like Conv T cells; FNA; n=12, 7 | 1.39 ± 0.191 | 1.40 ± 0.249 |
| Stem Cell Memory-like Conv T cells; Core; n=11, 10 | 1.31 ± 0.224 | 1.73 ± 0.236 |
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
| Percenatge of total memory Conv T cells | Healthy Participants | Participants With NOT1D |
|---|---|---|
| TFH cells; ; FNA; n=12, 8 | 24.09 ± 2.913 | 17.09 ± 3.651 |
| TFH cells; Core; n=11,10 | 21.94 ± 3.335 | 25.86 ± 3.491 |
| PD-1+ ICOS+ TFH cells; FNA; n=8,4 | 0.89 ± 0.356 | 2.15 ± 0.545 |
| PD-1+ ICOS+ TFH cells; Core; n=6,10 | 1.72 ± 1.239 | 1.71 ± 0.859 |
| TH17 cells;FNA; n=12,8 | 7.73 ± 1.122 | 6.96 ± 1.289 |
| TH17 cells; Core; n=11,10 | 5.38 ± 0.915 | 5.33 ± 0.977 |
| TH1 cells; FNA; n=12,8 | 14.08 ± 2.340 | 15.05 ± 2.777 |
| TH1 cells; Core; n=11,10 | 16.09 ± 1.858 | 22.12 ± 1.970 |
| TH1 TH17 cells; FNA; n=10,4 | 2.97 ± 0.510 | 3.07 ± 0.728 |
| TH1 TH17 cells; Core; n=10,10 | 3.08 ± 0.553 | 2.49 ± 0.559 |
| TH1 TH17 TH2 T cells; FNA; n=10,4 | 1.87 ± 0.371 | 1.44 ± 0.488 |
| TH1 TH17 TH2 T cells; Core; n=10,10 | 2.01 ± 0.390 | 1.63 ± 0.409 |
| TH1 TH2 cells; FNA; n=12,6 | 6.20 ± 0.910 | 5.68 ± 1.250 |
| TH1 TH2 cells; Core; n=10, 10 | 9.25 ± 1.130 | 8.83 ± 1.147 |
| TH2 cells; FNA; n=12,8 | 20.82 ± 2.168 | 18.67 ± 2.562 |
| TH2 cells; Core; n=11,10 | 19.24 ± 1.685 | 15.29 ± 1.821 |
| TH22 cells; FNA; n=12,4 | 1.51 ± 0.336 | 1.46 ± 0.530 |
| TH22 cells; Core; n=10, 10 | 1.49 ± 0.308 | 1.50 ± 0.311 |
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.
| Percentage of total memory Reg T cells | Healthy Participants | Participants With NOT1D |
|---|---|---|
| TFH cells-like Reg T cells; FNA; n=11, 5 | 13.52 ± 2.224 | 13.22 ± 2.869 |
| TFH cells-like Reg T cells; Core; n=9, 10 | 13.44 ± 1.884 | 12.71 ± 1.926 |
| PD-1+ ICOS+ TFH cells-like Reg T cells;FNA;n=2,3 | NA ± NA | NA ± NA |
| PD-1+ ICOS+ TFH cells-like Reg T cells;Core;n=4,5 | NA ± NA | NA ± NA |
| TH1 cells-like Reg T cells;FNA; n=11,5 | 7.19 ± 1.428 | 12.09 ± 1.900 |
| TH1 cells-like Reg T cells;Core;n=8, 10 | 7.43 ± 1.211 | 10.72 ± 1.167 |
| TH1 TH17-like Reg T cells;FNA; n=1, 1 | NA ± NA | NA ± NA |
| TH1 TH17-like Reg T cells;Core; n=0,2 | — | NA ± NA |
| TH1 TH17 TH2 cells-like Reg T cells;FNA; n=7, 4 | 2.88 ± 0.599 | 3.17 ± 0.845 |
| TH1 TH17 TH2 cells-like Reg T cells;Core;n=5,5 | 2.25 ± 1.381 | 5.05 ± 1.348 |
| TH1 TH2 cells-like Reg T cells;FNA; n=11, 4 | 9.08 ± 1.092 | 10.52 ± 1.813 |
| TH1 TH2 cells-like Reg T cells;Core; n=10,10 | 11.15 ± 1.434 | 11.45 ± 1.460 |
| TH17 cells-like Reg T cells;FNA; n=11, 4 | 8.18 ± 1.547 | 9.64 ± 2.146 |
| TH17 cells-like Reg T cells;Core; n=10, 10 | 6.23 ± 1.507 | 5.70 ± 1.582 |
| TH2 cells-like Reg T cells;FNA; n=12, 8 | 27.38 ± 2.749 | 29.63 ± 3.305 |
| TH2 cells-like Reg T cells;Core; n=11, 10 | 28.28 ± 2.386 | 24.86 ± 2.522 |
| TH22 cells-like Reg T cells;FNA; n=6,3 | 2.30 ± 0.653 | 2.95 ± 0.950 |
| TH22 cells-like Reg T cells;Core; n=7,7 | 2.28 ± 0.619 | 2.45 ± 0.610 |
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
| Percentage of CD4 T cells | Healthy Participants | Participants With NOT1D |
|---|---|---|
| Reg T cells; FNA; n=10, 4 | 11.98 ± 0.750 | 11.52 ± 1.067 |
| Reg T cells; Core; n=5, 9 | 12.11 ± 0.871 | 13.05 ± 0.597 |
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
| Percentage of CD8 T cells | Healthy Participants | Participants With NOT1D |
|---|---|---|
| CD69+ CD8 cells; FNA; n=10, 4 | 16.80 ± 2.837 | 17.97 ± 4.201 |
| CD69+ CD8 cells; Core; n=5, 9 | 18.74 ± 4.287 | 23.12 ± 3.117 |
| Ki67+ CD8 cells; FNA; n=9, 3 | 4.82 ± 0.689 | 3.33 ± 1.189 |
| Ki67+ CD8 cells; Core; n=4, 6 | 6.90 ± 1.025 | 3.99 ± 0.785 |
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
| Percentage of T Reg cells | Healthy Participants | Participants With NOT1D |
|---|---|---|
| CD15s+ Reg T cells; FNA; n=9, 4 | 12.99 ± 2.022 | 8.13 ± 2.327 |
| CD15s+ Reg T cells; Core; n=4, 8 | 20.10 ± 4.531 | 11.89 ± 5.044 |
| CD69+ Reg T cells; FNA; n=10, 4 | 48.55 ± 3.666 | 59.74 ± 4.510 |
| CD69+ Reg T cells; Core; n=5, 9 | 47.48 ± 2.744 | 53.37 ± 2.708 |
| Helios+ Reg T cells; FNA; n=10, 4 | 80.88 ± 1.559 | 79.23 ± 1.929 |
| Helios+ Reg T cells; Core; n=5, 9 | 81.68 ± 2.180 | 79.10 ± 1.968 |
| Ki67+ T Reg cells; FNA; n=8, 4 | 8.02 ± 1.855 | 4.80 ± 2.072 |
| Ki67+ T Reg cells; Core; n=4, 7 | 8.76 ± 0.893 | 5.38 ± 0.996 |
| Memory Reg T cells; FNA; n=10, 4 | 47.10 ± 2.842 | 48.55 ± 3.788 |
| Memory Reg T cells; Core; n=5, 9 | 53.13 ± 3.036 | 51.25 ± 2.818 |
| Resting Reg T cells; FNA; n=9, 4 | 38.09 ± 3.392 | 27.64 ± 4.692 |
| Resting Reg T cells; Core; n=5, 9 | 32.54 ± 3.828 | 26.37 ± 3.080 |
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
| Percentage of total Conv T cells | Healthy Participants | Participants With NOT1D |
|---|---|---|
| CD15s+ Conv T cells;FNA;n=9, 4 | 3.02 ± 0.448 | 1.64 ± 0.533 |
| CD15s+ Conv T cells; Core; n=5, 8 | 5.85 ± 0.892 | 3.66 ± 0.978 |
| CD69+ Conv T cells;FNA;n=10, 4 | 27.95 ± 3.498 | 28.86 ± 5.346 |
| CD69+ Conv T cells; Core; n=5, 9 | 27.54 ± 3.870 | 31.73 ± 2.943 |
| Helios+ Conv T cells ; FNA;n=10, 4 | 5.14 ± 0.750 | 5.27 ± 0.980 |
| Helios+ Conv T cells ; Core; n=5, 9 | 5.85 ± 0.644 | 5.44 ± 0.570 |
| Ki67+ Conv T cells; FNA;n=9, 4 | 4.07 ± 0.760 | 0.86 ± 0.935 |
| Ki67+ Conv T cells ; Core; n=5, 8 | 4.72 ± 0.502 | 2.45 ± 0.505 |
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
| Percentage of total memory Conv cells | Healthy Participants | Participants With NOT1D |
|---|---|---|
| CD15s+ Memory Conv T cells; FNA; n=9, 4 | 6.39 ± 0.889 | 3.12 ± 1.042 |
| CD15s+ Memory Conv T cells; Core; n=5, 8 | 8.80 ± 1.390 | 6.06 ± 1.585 |
| CD69+ Memory Conv T cells; FNA; n=10, 4 | 45.74 ± 3.604 | 45.74 ± 5.662 |
| CD69+ Memory Conv T cells; Core; n=5, 9 | 42.91 ± 3.198 | 47.03 ± 2.314 |
| Helios+ Memory Conv T cells; FNA; n=9, 4 | 7.68 ± 1.312 | 6.35 ± 2.661 |
| Helios+ Memory Conv T cells; Core; n=5, 9 | 8.82 ± 2.144 | 7.59 ± 0.794 |
| Ki67+ Memory Conv T cells; FNA; n=9, 4 | 4.32 ± 0.659 | 1.62 ± 0.777 |
| Ki67+ Memory Conv T cells; Core; n=4, 8 | 4.63 ± 0.482 | 3.04 ± 0.558 |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/ incapacity, is a congenital anomaly/ birth defect or other situations.
| Participants | Healthy Participants | Participants With NOT1D |
|---|---|---|
| Any SAE | 0 | 0 |
| Any non-SAE | 9 | 5 |
Participants were asked to complete Pre-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The number of participants who underwent procedure under local anesthetics have been presented.
| Participants | Healthy Participants | Participants With NOT1D |
|---|---|---|
| Number of Participants Undergoing Procedure Under Local Anesthetics | 6 | 7 |
Participants were asked to complete Pre-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The number of participants who underwent iLN biopsy under local anesthetics have been presented.
| Participants | Healthy Participants | Participants With NOT1D |
|---|---|---|
| Number of Participants Undergoing iLN Biopsy Under Local Anesthetics | 0 | 0 |
Participants were asked to complete Pre-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The different reasons have been listed as follows; have friend with diabetes mellitus (DM)/ to progress knowledge, to improve medicines development, participating in the study because of the honorarium, any other reason not listed above was categorized as "other" and participants having all three reasons as listed above to participate in the study were included in "All reasons" category
| Participants | Healthy Participants | Participants With NOT1D |
|---|---|---|
| Have friend with DM/ to progress knowledge | 2 | 4 |
| To improve medicines development | 10 | 4 |
| Honorarium | 0 | 0 |
| Other | 0 | 1 |
| All reasons | 0 | 1 |
Participants were asked to complete Pre-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The number of participants with extreme anxiety towards the procedure have been presented.
| Participants | Healthy Participants | Participants With NOT1D |
|---|---|---|
| Number of Participants With Extreme Anxiety Towards the Lymph Node Biopsy | 0 | 0 |
Participants were asked to complete Pre-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The number of participants looking forward to undergo the procedure have been presented.
| Participants | Healthy Participants | Participants With NOT1D |
|---|---|---|
| Number of Participants Looking Forward to Undergo the Procedure | 1 | 0 |
Participants were asked to complete Post-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The aspects better explained were as follows; itself, anesthetic procedure, after-care, none and any other procedure not listed above was categorized as "other".
| Participants | Healthy Participants | Participants With NOT1D |
|---|---|---|
| Procedure itself | 1 | 1 |
| Anesthetic procedure | 0 | 0 |
| After-care | 1 | 0 |
| None | 9 | 9 |
| Other | 1 | 0 |
Participants were asked to complete Post-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The number of participants who considered to undergo procedure another time have been presented.
| Participants | Healthy Participants | Participants With NOT1D |
|---|---|---|
| Number of Participants Who Considered to Undergo Lymph Node Biopsy Procedure Another Time | 10 | 9 |
Participants were asked to complete Post-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. Participants who were encouraged in study for iLN biopsy have been presented.
| Participants | Healthy Participants | Participants With NOT1D |
|---|---|---|
| Number of Participants Who Were Encouraged to be Included in Study for iLN Biopsy | 11 | 8 |
Participants were asked to complete Post-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. Participants who appreciated receiving study feedback have been presented.
| Participants | Healthy Participants | Participants With NOT1D |
|---|---|---|
| Number of Participants Who Appreciated Receiving Study Feedback | 12 | 10 |
Collected over Serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Day 14.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Healthy Participants | 0/12 (0%) | 0/12 (0%) | 9/12 (75%) |
| Participants With NOT1D | 0/10 (0%) | 0/10 (0%) | 5/10 (50%) |
| Event | Healthy Participants | Participants With NOT1D |
|---|---|---|
| Procedural painInjury, poisoning and procedural complications | 6/12 | 4/10 |
| Post procedural contusionInjury, poisoning and procedural complications | 4/12 | 4/10 |
| NauseaGastrointestinal disorders | 1/12 | 0/10 |
| FatigueGeneral disorders | 1/12 | 0/10 |
| Age, Continuous(Years) | Healthy Participants | Participants With NOT1D | Total |
|---|---|---|---|
| Mean | 28.6 ± 5.53 | 27.0 ± 5.35 | 27.9 ± 5.38 |
| Sex: Female, Male(Participants) | Healthy Participants | Participants With NOT1D | Total |
|---|---|---|---|
| Female | 4 | 4 | 8 |
| Male | 8 | 6 | 14 |
| Race/Ethnicity, Customized(Participants) | Healthy Participants | Participants With NOT1D | Total |
|---|---|---|---|
| White - White/Caucasian/European Heritage | 12 | 10 | 22 |
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