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NCT Number: NCT05841719

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

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

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Key information

Conditions

Cardiovascular Risk Factors Autoimmune Diseases Immune System Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Scuola dell'Infanzia Comunale Don Angelo Luzzini

Cantalupo, Milan, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Screening test

Other

Capillary blood sampling by finger-prick devices and second confirmatory venous sampling when needed.

Primary outcomes

  1. feasibility and acceptability

    Time frame: through study completion, an average of 1 year

    To assess feasibility and acceptability of the screening program

  2. blood glucose and lipids level (mg/dl)

    Time frame: through study completion, an average of 1 year

    Capillary blood sampling will be performed by finger-prick devices.

  3. IAA, GADA65, ZnT8, IA2 autoantibodies (U/ml)

    Time frame: within a few days

    Capillary blood sampling will be performed by finger-prick devices.

  4. anti-transglutaminase autoantibodies (UA)

    Time frame: through study completion, an average of 1 year

    Capillary blood sampling will be performed by finger-prick devices.

  5. systolic and diastolic blood pressure (mmHg)

    Time frame: through study completion, an average of 1 year

    Blood pressure measurement will be performed through a sphygmomanometer.

  6. HbA1c (mmol/mol)

    Time frame: through study completion, an average of 1 year

    Glycated hemoglobin will be measured by finger-prick devices.

Sponsors and collaborators

Lead sponsor

Emanuele Bosi

Other

Collaborators

  • Italian Diabetes Foundation

Registry information

Official study title

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

Acronym: UNISCREEN

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
May 3, 2023
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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