An interventional study of Screening test in Cardiovascular Risk Factors and Autoimmune Diseases, sponsored by Emanuele Bosi. Completed at 1 site in Italy. Per ClinicalTrials.gov, last updated 2024-03-06.
Sponsored by Emanuele Bosi · Not applicable, Interventional, and Other
This study represents a model for a public health program based on a general population screening for the most prevalent chronic metabolic, cardiovascular and autoimmune diseases across adulthood, childhood and adolescence. The main purpose is to assess feasibility and acceptability of using a capillary screening for this purpose. Secondly, it will be possibile to identify people at increased risk of developing one of these health conditions as well as those who are at pre-symptomatic clinical stages. Risk assessment is needed to identify prevention strategies; early diagnosis allows to start early treatment interventions aimed at reducing lifetime complications.This interventional study will enroll volunteers from Cantalupo, a locality belonging to the Municipality of Cerro Maggiore (Milan). Participants will be offered to undergo two capillary blood sampling to test blood glucose levels, glycated haemoglobin, total cholesterol, HDL-c, LDL-c, triglycerides and specific antibodies for type 1 diabetes and celiac disease. In case a participant screens positive for type I diabetes and/or celiac disease, they will be subsequently invited to undergo a new confirmatory blood draw on venous blood. Blood pressure will be also measured for each participant
This is a low-risk, single-center, interventional study, assessing whether capillary screening for an early staging of the most prevalent chronic metabolic, cardiovascular and autoimmune diseases is feasible at a population-based level. The study will enroll volunteers from Cantalupo, a locality of 3095 inhabitants belonging to the Municipality of Cerro Maggiore (Milan). The main purpose is to assess feasibility and acceptability of using this public intervention. Secondary outcomes are: (i) measurement of the specific disease markers; (ii) estimation of the prevalence of the identified diseases within the population; (iii) estimation of the prevalence of the identified diseases across age classes; (iv) correlation of study disease indicators with demographics, anthropometrics and clinical data of the population , v) multiparametric risk assessment. Participants will be offered to undergo a capillary blood sampling to test blood glucose levels, glycated haemoglobin, total cholesterol , HDL-c, LDL-c, triglycerides, Glutamic Acid Decarboxylase (GADA), Insulinoma-Associated-2/Tyrosine Phosphatase (IA-2A), Insulin (IAA), Zinc Transporter-8 Autoantibodies (ZnT8A) for type I diabetes and tissue transglutaminase antibodies for celiac disease. Glucose and lipid blood levels will be detected at the time of the screening. The results of autoantibodies research for celiac disease and type 1 diabetes will be available within a few days. In case a participant screens positive for type I diabetes and/or celiac disease, they will be subsequently invited to undergo a new confirmatory blood draw on venous blood. Blood pressure will be also measured for each participant.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 1,535 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Emanuele Bosi is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion criteria:
No exclusion criteria.
capillary sampling and questionnaires to test feasibility and acceptability
Other: Screening test
Capillary blood sampling by finger-prick devices and second confirmatory venous sampling when needed.
feasibility and acceptability
To assess feasibility and acceptability of the screening program
Time frame: through study completion, an average of 1 year
blood glucose and lipids level (mg/dl)
Capillary blood sampling will be performed by finger-prick devices.
Time frame: through study completion, an average of 1 year
IAA, GADA65, ZnT8, IA2 autoantibodies (U/ml)
Capillary blood sampling will be performed by finger-prick devices.
Time frame: within a few days
anti-transglutaminase autoantibodies (UA)
Capillary blood sampling will be performed by finger-prick devices.
Time frame: through study completion, an average of 1 year
systolic and diastolic blood pressure (mmHg)
Blood pressure measurement will be performed through a sphygmomanometer.
Time frame: through study completion, an average of 1 year
HbA1c (mmol/mol)
Glycated hemoglobin will be measured by finger-prick devices.
Time frame: through study completion, an average of 1 year
Plan to share: No
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Emanuele Bosi