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

March 5, 2024 updated by: Emanuele Bosi

General Population Universal Capillary Screening for Chronic Autoimmune, Metabolic and Cardiovascular Diseases (UNISCREEN): 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

1535

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Milan
      • Cantalupo, Milan, Italy
        • Scuola dell'Infanzia Comunale Don Angelo Luzzini

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Population from Cantalupo, locality of the Municipality of Cerro Maggiore (MI).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
feasibility and acceptability
Time Frame: through study completion, an average of 1 year
To assess feasibility and acceptability of the screening program
through study completion, an average of 1 year
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.
through study completion, an average of 1 year
IAA, GADA65, ZnT8, IA2 autoantibodies (U/ml)
Time Frame: within a few days
Capillary blood sampling will be performed by finger-prick devices.
within a few days
anti-transglutaminase autoantibodies (UA)
Time Frame: through study completion, an average of 1 year
Capillary blood sampling will be performed by finger-prick devices.
through study completion, an average of 1 year
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.
through study completion, an average of 1 year
HbA1c (mmol/mol)
Time Frame: through study completion, an average of 1 year
Glycated hemoglobin will be measured by finger-prick devices.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 1 year
IAA, GADA65, ZnT8, IA2 autoantibodies (U/ml)
Time Frame: within a few days
Capillary blood sampling will be performed by finger-prick devices.
within a few days
anti-transglutaminase autoantibodies (UA)
Time Frame: through study completion, an average of 1 year
Capillary blood sampling will be performed by finger-prick devices.
through study completion, an average of 1 year
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.
through study completion, an average of 1 year
HbA1c (mmol/mol)
Time Frame: through study completion, an average of 1 year
Glycated hemoglobin will be measured by finger-prick devices.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emanuele Bosi

Collaborators

Italian Diabetes Foundation

Investigators

  • Principal Investigator: Emanuele Bosi, MD, San Raffaele Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2023

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

January 1, 2024

Study Registration Dates

First Submitted

February 3, 2023

First Submitted That Met QC Criteria

April 24, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Actual)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNISCREEN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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