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

NCT05841719 | Completed

• 1 other identifier: UNISCREEN
• Study Type: interventional
• Target: 1,535
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiovascular Risk Factors; Autoimmune Diseases

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Population from Cantalupo, locality of the Municipality of Cerro Maggiore (MI).

OTHER

capillary sampling and questionnaires to test feasibility and acceptability

Other: Screening test

Interventions

Screening test OTHER

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

Population from Cantalupo, locality of the Municipality of Cerro Maggiore (MI).

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Emanuele Bosi: lead
• Italian Diabetes Foundation: collaborator

Study Sites (1)

Scuola dell'Infanzia Comunale Don Angelo Luzzini

Cantalupo, Milan, Italy

Location

Related Publications (6)

• Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Back M, Benetos A, Biffi A, Boavida JM, Capodanno D, Cosyns B, Crawford C, Davos CH, Desormais I, Di Angelantonio E, Franco OH, Halvorsen S, Hobbs FDR, Hollander M, Jankowska EA, Michal M, Sacco S, Sattar N, Tokgozoglu L, Tonstad S, Tsioufis KP, van Dis I, van Gelder IC, Wanner C, Williams B; ESC National Cardiac Societies; ESC Scientific Document Group. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J. 2021 Sep 7;42(34):3227-3337. doi: 10.1093/eurheartj/ehab484. No abstract available.

  PMID: 34458905 BACKGROUND

• Ziegler AG, Hoffmann GF, Hasford J, Larsson HE, Danne T, Berner R, Penno M, Koralova A, Dunne J, Bonifacio E. Screening for asymptomatic beta-cell autoimmunity in young children. Lancet Child Adolesc Health. 2019 May;3(5):288-290. doi: 10.1016/S2352-4642(19)30028-8. Epub 2019 Feb 10. No abstract available.

  PMID: 30745054 BACKGROUND

• Ziegler AG, Kick K, Bonifacio E, Haupt F, Hippich M, Dunstheimer D, Lang M, Laub O, Warncke K, Lange K, Assfalg R, Jolink M, Winkler C, Achenbach P; Fr1da Study Group. Yield of a Public Health Screening of Children for Islet Autoantibodies in Bavaria, Germany. JAMA. 2020 Jan 28;323(4):339-351. doi: 10.1001/jama.2019.21565.

  PMID: 31990315 BACKGROUND

• US Preventive Services Task Force; Bibbins-Domingo K, Grossman DC, Curry SJ, Barry MJ, Davidson KW, Doubeni CA, Ebell M, Epling JW Jr, Herzstein J, Kemper AR, Krist AH, Kurth AE, Landefeld CS, Mangione CM, Phipps MG, Silverstein M, Simon MA, Tseng CW. Screening for Celiac Disease: US Preventive Services Task Force Recommendation Statement. JAMA. 2017 Mar 28;317(12):1252-1257. doi: 10.1001/jama.2017.1462.

  PMID: 28350936 BACKGROUND

• Angiulli S, Merolla A, Borgonovo E, De Lorenzo R, Spadoni S, Fontana B, Manganaro G, Rela E, Bongiovanni A, Peracino R, Bellino C, Pata G, Bianconi E, Martinenghi S, Ulivi F, Renzi C, Bosi E; UNISCREEN Study Group. Universal capillary screening for chronic autoimmune, metabolic and cardiovascular diseases: feasibility and acceptability of the UNISCREEN study. Front Public Health. 2025 Feb 11;13:1506240. doi: 10.3389/fpubh.2025.1506240. eCollection 2025.

  PMID: 40008147 DERIVED

• Merolla A, De Lorenzo R, Ferrannini G, Renzi C, Ulivi F, Bazzigaluppi E, Lampasona V, Bosi E. Universal screening for early detection of chronic autoimmune, metabolic and cardiovascular diseases in the general population using capillary blood (UNISCREEN): low-risk interventional, single-centre, pilot study protocol. BMJ Open. 2024 Mar 5;14(3):e078983. doi: 10.1136/bmjopen-2023-078983.

  PMID: 38448070 DERIVED

MeSH Terms

Conditions

Autoimmune Diseases

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Emanuele Bosi, MD

  San Raffaele Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Professor of Internal Medicine, Head, General Medicine, Diabetes & Endocrinology

Model Details: capillary sampling

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: May 3, 2023
• Study Start: April 22, 2023
• Primary Completion: December 31, 2023
• Study Completion: January 1, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)