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

Autoimmune Diseases Clinical Trial

— UNISCREEN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05841719
• Other study ID #: UNISCREEN
• Status: Completed
• Phase: N/A
• Start date: April 22, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: March 2024
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1535
• Est. completion date: January 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Autoimmune Diseases
• Cardiovascular Diseases
• Cardiovascular Risk Factors

Intervention

Other:
• Screening test
Capillary blood sampling by finger-prick devices and second confirmatory venous sampling when needed.

Locations

Country	Name	City	State
Italy	Scuola dell'Infanzia Comunale Don Angelo Luzzini	Cantalupo	Milan

Sponsors (2)

Lead Sponsor	Collaborator
Emanuele Bosi	Italian Diabetes Foundation

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View Citation

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. Erratum In: Eur Heart J. 2022 Nov 7;43(42):4468. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility and acceptability	To assess feasibility and acceptability of the screening program	through study completion, an average of 1 year
Primary	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
Primary	IAA, GADA65, ZnT8, IA2 autoantibodies (U/ml)	Capillary blood sampling will be performed by finger-prick devices.	within a few days
Primary	anti-transglutaminase autoantibodies (UA)	Capillary blood sampling will be performed by finger-prick devices.	through study completion, an average of 1 year
Primary	systolic and diastolic blood pressure (mmHg)	Blood pressure measurement will be performed through a sphygmomanometer.	through study completion, an average of 1 year
Primary	HbA1c (mmol/mol)	Glycated hemoglobin will be measured by finger-prick devices.	through study completion, an average of 1 year