Universal Capillary Screening for Chronic Autoimmune, Metabolic and Cardiovascular Diseases: Feasibility and Acceptability Pilot Study.

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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General Population Universal Capillary Screening for Chronic Autoimmune, Metabolic and Cardiovascular Diseases (UNISCREEN): Feasibility and Acceptability Pilot Study.

Conditions
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Cardiovascular Risk Factors, Autoimmune Diseases

Intervention / Treatment
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* Other: Screening test


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Residency in Cantalupo, locality of the Municipality of Cerro Maggiore (MI) Age between 1 and 100 years Ability to understand the purpose of the project and to sign the informed consent. Exclusion criteria: No exclusion criteria.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: capillary sampling
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Population from Cantalupo, locality of the Municipality of Cerro Maggiore (MI).<br>capillary sampling and questionnaires to test feasibility and acceptability | Other: Screening test<br>* Capillary blood sampling by finger-prick devices and second confirmatory venous sampling when needed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feasibility and acceptability | To assess feasibility and acceptability of the screening program | 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. | 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. | within a few days | 
| anti-transglutaminase autoantibodies (UA) | Capillary blood sampling will be performed by finger-prick devices. | through study completion, an average of 1 year | 
| systolic and diastolic blood pressure (mmHg) | Blood pressure measurement will be performed through a sphygmomanometer. | through study completion, an average of 1 year | 
| HbA1c (mmol/mol) | Glycated hemoglobin will be measured by finger-prick devices. | through study completion, an average of 1 year |