Clinical trial NCT05841719: Universal Capillary Screening for Chronic Autoimmune, Metabolic and Cardiovascular Diseases: Feasibility and Acceptability Pilot Study.
Official title: General Population Universal Capillary Screening for Chronic Autoimmune, Metabolic and Cardiovascular Diseases (UNISCREEN): Feasibility and Acceptability Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factors
Autoimmune Diseases
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
Collaborators: name: Italian Diabetes Foundation
First posted: 2023-05-03
Enrollment: 1535
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: capillary sampling
Primary purpose: OTHER

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: feasibility and acceptability
timeFrame: through study completion, an average of 1 year
measure: blood glucose and lipids level (mg/dl)
timeFrame: through study completion, an average of 1 year
measure: IAA, GADA65, ZnT8, IA2 autoantibodies (U/ml)
timeFrame: within a few days
measure: anti-transglutaminase autoantibodies (UA)
timeFrame: through study completion, an average of 1 year
measure: systolic and diastolic blood pressure (mmHg)
timeFrame: through study completion, an average of 1 year
measure: HbA1c (mmol/mol)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cantalupo
country: Italy
facility: Scuola dell'Infanzia Comunale Don Angelo Luzzini
state: Milan
Study officials:
affiliation: San Raffaele Institute
name: Emanuele Bosi, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.