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Not yet recruitingNCT07832656LAUNCH-T2DUpdated Sep 28, 2026

Proteome-Wide Association and LLM-Based Prioritization of Type 2 Diabetes Protein Targets

An observational study in Type 2 Diabetes Mellitus (DM), sponsored by Louisiana State University Health Sciences Center in New Orleans. Not yet recruiting. Open to participants aged 40 Years to 84 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Louisiana State University Health Sciences Center in New Orleans · Observational

Updated Sep 28, 2026Eligibility revisedPrimary outcomes revisedGo to Updates ↓
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
31,994
Ages
40 Years to 84 Years
Sex
All
01

Study summary

Type 2 diabetes is a common condition in which the body has difficulty controlling blood sugar. This study will use existing genetic, protein, and health data from prior research studies to identify blood proteins that may play a role in type 2 diabetes. The study will not recruit participants, provide treatment, or collect new samples. Researchers will use computer-based analyses to identify and prioritize protein targets for future laboratory and clinical research. The goal is to support the development of better approaches for understanding, preventing, and treating type 2 diabetes.

Read the detailed description

Type 2 diabetes is a major cause of illness and health disparities. Genetic association studies can identify regions of the genome associated with disease risk, but they do not always identify the proteins or biological mechanisms that contribute to disease development. This project will conduct a retrospective secondary analysis of existing, controlled-access genetic, proteomic, and phenotype data, including data accessed through the United Kingdom Biobank (UK Biobank) and other previously collected datasets. No new participants will be recruited, enrolled, contacted, treated, or followed as part of this study.

The study will use proteome-wide association methods to evaluate whether genetically predicted circulating protein levels are associated with type 2 diabetes risk. Analyses will consider evidence across African American and European American datasets when available, with attention to population-specific and shared signals. Statistical genetic evidence will be integrated with relevant biological and clinical information to prioritize protein targets that may have a causal role in type 2 diabetes.

Large language model-based methods will be used as a structured evidence-synthesis tool to organize and summarize publicly available information relevant to prioritized proteins, including biological function, disease relevance, and potential therapeutic tractability. All computational results will be reviewed by the research team. The project will generate reproducible analytic workflows, a ranked list of candidate protein targets, and hypotheses for future experimental validation. Findings are intended for research use and will not be used to make clinical decisions for individual patients.

02

Conditions studied

  • Type 2 Diabetes Mellitus (DM)
03

In context

Diabetes Mellitus, Type 2

10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.

This study's planned enrollment of 31,994 is above the median of 300 across 1,741 observational studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Louisiana State University Health Sciences Center in New Orleans is the lead sponsor of 72 studies on the registry; 12 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Sep 28, 2026. See what changed

Ages eligible
40 Years to 84 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Existing adult participants from the UK Biobank and Multi-Ethnic Study of Atherosclerosis with available genetic and OLINK proteomic data, including African American and European American/European ancestry participants. Type 2 diabetes GWAS summary statistics from the Million Veteran Program will be integrated for association analyses. No new participants will be recruited or contacted.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants enrolled in the source studies who were aged 40 to 84 years at enrollment.
  • Availability of genetic data and plasma proteomic data for population-specific protein prediction modeling.
  • Participants with or without type 2 diabetes, depending on the source dataset and analytic objective.

Exclusion criteria

Exclusion Criteria:

  • Participants younger than 40 years or older than 84 years at enrollment in the source studies.
  • Participants lacking genetic data or plasma proteomic data required for protein prediction modeling.

This study will conduct a retrospective secondary analysis of existing, controlled-access datasets. No new participants will be recruited or contacted. Type 2 diabetes genome-wide association summary statistics will also be used for association analyses; the participant-level eligibility criteria above apply to individual-level source-study records used for protein prediction modeling.

05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
31,994 participants (estimated)
Patient registry
No

Groups and cohorts

  • African American Participants

    Retrospective analysis of existing genetic and OLINK proteomic data to develop and validate population-specific protein prediction models and evaluate genetically predicted proteins associated with type 2 diabetes risk.

  • European American Participants

    Retrospective analysis of existing genetic and OLINK proteomic data to develop and validate population-specific protein prediction models and evaluate genetically predicted proteins associated with type 2 diabetes risk.

06

What researchers measure

Primary outcomes

  1. Performance of Population-Specific Protein Prediction Models

    Cross-validated and external validation coefficients of determination (R-squared values) for prediction models of 2,943 plasma proteins based on single-nucleotide polymorphisms located near the genes encoding the corresponding proteins (cis variants). Models with reproducible performance (R-squared greater than 0.01) will be retained.

    Time frame: Up to 12 months

Secondary outcomes

  1. Genetically Predicted Protein Associations With Type 2 Diabetes Risk

    Number and effect estimates of proteins associated with type 2 diabetes risk after integration of validated population-specific protein prediction models with type 2 diabetes genome-wide association summary statistics. Statistical significance will be assessed using false discovery rate less than 0.05.

    Time frame: Up to 12 months

  2. Prioritized Protein Targets With Citation-Grounded Functional Evidence

    Number of proteins identified through proteome-wide association analyses that are assigned a structured, citation-grounded functional evidence profile and prioritization score using retrieval-augmented large language model-assisted annotation and expert review.

    Time frame: Up to 12 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared because this study uses controlled-access data from external sources, including the UK Biobank and the Multi-Ethnic Study of Atherosclerosis, that are subject to source-specific data use agreements and participant privacy protections. The study team does not have authority to redistribute these data. To support transparency and reproducibility, analytic code, study documentation, and aggregate, non-identifiable results will be shared when permitted by applicable agreements.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Eligibility
3 inclusion criteria added; 3 exclusion criteria added; 1 criterion removed
What changed in the criteria
  • RemovedNo new participants will be recruited for this study. The study will conduct a retrospective secondary analysis of existing, controlled-access datasets. Eligible records are from adult participants aged 40 to 84 years at enrollment in the source studies who have available genetic data and plasma proteomic data for population-specific protein prediction modeling. Participants with and without type 2 diabetes may be included, depending on the source dataset and analytic objective. Type 2 diabetes genome-wide association summary statistics will also be used; no individual-level participant contact or enrollment will occur.
Inclusion criteria
  • AddedParticipants enrolled in the source studies who were aged 40 to 84 years at enrollment.
  • AddedAvailability of genetic data and plasma proteomic data for population-specific protein prediction modeling.
  • AddedParticipants with or without type 2 diabetes, depending on the source dataset and analytic objective.
Exclusion criteria
  • AddedParticipants younger than 40 years or older than 84 years at enrollment in the source studies.
  • AddedParticipants lacking genetic data or plasma proteomic data required for protein prediction modeling.
  • AddedThis study will conduct a retrospective secondary analysis of existing, controlled-access datasets. No new participants will be recruited or contacted. Type 2 diabetes genome-wide association summary statistics will also be used for association analyses; the participant-level eligibility criteria above apply to individual-level source-study records used for protein prediction modeling.
Sep 28, 2026
Primary outcomes
1 description edited
What changed in the outcomes
  • DescriptionPerformance of Population-Specific Protein Prediction Models: how it is measured was reworded
Sep 28, 2026
Secondary outcomes
1 description edited
What changed in the outcomes
  • DescriptionPrioritized Protein Targets With Citation-Grounded Functional Evidence: how it is measured was reworded
Sep 28, 2026
Show all 1 update
  1. Sep 28, 2026
    Eligibility 3 inclusion criteria added; 3 exclusion criteria added; 1 criterion removed
    What changed in the criteria
    • RemovedNo new participants will be recruited for this study. The study will conduct a retrospective secondary analysis of existing, controlled-access datasets. Eligible records are from adult participants aged 40 to 84 years at enrollment in the source studies who have available genetic data and plasma proteomic data for population-specific protein prediction modeling. Participants with and without type 2 diabetes may be included, depending on the source dataset and analytic objective. Type 2 diabetes genome-wide association summary statistics will also be used; no individual-level participant contact or enrollment will occur.
    Inclusion criteria
    • AddedParticipants enrolled in the source studies who were aged 40 to 84 years at enrollment.
    • AddedAvailability of genetic data and plasma proteomic data for population-specific protein prediction modeling.
    • AddedParticipants with or without type 2 diabetes, depending on the source dataset and analytic objective.
    Exclusion criteria
    • AddedParticipants younger than 40 years or older than 84 years at enrollment in the source studies.
    • AddedParticipants lacking genetic data or plasma proteomic data required for protein prediction modeling.
    • AddedThis study will conduct a retrospective secondary analysis of existing, controlled-access datasets. No new participants will be recruited or contacted. Type 2 diabetes genome-wide association summary statistics will also be used for association analyses; the participant-level eligibility criteria above apply to individual-level source-study records used for protein prediction modeling.
    Primary outcomes 1 description edited
    What changed in the outcomes
    • DescriptionPerformance of Population-Specific Protein Prediction Models: how it is measured was reworded
    Secondary outcomes 1 description edited
    What changed in the outcomes
    • DescriptionPrioritized Protein Targets With Citation-Grounded Functional Evidence: how it is measured was reworded
    + 1 other change: description

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07832656
Lead sponsor
Louisiana State University Health Sciences Center in New Orleans
Responsible party
Sponsor
First posted
Sep 22, 2026
Start date
Sep 15, 2026 (estimated)
Primary completion
Jul 2, 2027 (estimated)
Completion
Aug 2, 2027 (estimated)
Last update
Sep 28, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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