Universal Capillary Screening for Chronic Autoimmune, Metabolic and Cardiovascular Diseases: Feasibility and Acceptability Pilot Study. (UNISCREEN)
Primary Purpose
Cardiovascular Risk Factors, Autoimmune Diseases
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Screening test
Sponsored by
About this trial
This is an interventional other trial for Cardiovascular Risk Factors
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.
Sites / Locations
- Scuola dell'Infanzia Comunale Don Angelo LuzziniRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Population from Cantalupo, locality of the Municipality of Cerro Maggiore (MI).
Arm Description
capillary sampling and questionnaires to test feasibility and acceptability
Outcomes
Primary Outcome Measures
feasibility and acceptability
To assess feasibility and acceptability of the screening program
blood glucose and lipids level (mg/dl)
Capillary blood sampling will be performed by finger-prick devices.
IAA, GADA65, ZnT8, IA2 autoantibodies (U/ml)
Capillary blood sampling will be performed by finger-prick devices.
anti-transglutaminase autoantibodies (UA)
Capillary blood sampling will be performed by finger-prick devices.
systolic and diastolic blood pressure (mmHg)
Blood pressure measurement will be performed through a sphygmomanometer.
HbA1c (mmol/mol)
Glycated hemoglobin will be measured by finger-prick devices.
Secondary Outcome Measures
Full Information
NCT ID
NCT05841719
First Posted
February 3, 2023
Last Updated
May 26, 2023
Sponsor
Emanuele Bosi
Collaborators
Italian Diabetes Foundation
1. Study Identification
Unique Protocol Identification Number
NCT05841719
Brief Title
Universal Capillary Screening for Chronic Autoimmune, Metabolic and Cardiovascular Diseases: Feasibility and Acceptability Pilot Study.
Acronym
UNISCREEN
Official Title
General Population Universal Capillary Screening for Chronic Autoimmune, Metabolic and Cardiovascular Diseases (UNISCREEN): Feasibility and Acceptability Pilot Study.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 22, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Emanuele Bosi
Collaborators
Italian Diabetes Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Risk Factors, Autoimmune Diseases
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
capillary sampling
Masking
None (Open Label)
Allocation
N/A
Enrollment
3095 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Population from Cantalupo, locality of the Municipality of Cerro Maggiore (MI).
Arm Type
Other
Arm Description
capillary sampling and questionnaires to test feasibility and acceptability
Intervention Type
Other
Intervention Name(s)
Screening test
Intervention Description
Capillary blood sampling by finger-prick devices and second confirmatory venous sampling when needed.
Primary Outcome Measure Information:
Title
feasibility and acceptability
Description
To assess feasibility and acceptability of the screening program
Time Frame
through study completion, an average of 1 year
Title
blood glucose and lipids level (mg/dl)
Description
Capillary blood sampling will be performed by finger-prick devices.
Time Frame
through study completion, an average of 1 year
Title
IAA, GADA65, ZnT8, IA2 autoantibodies (U/ml)
Description
Capillary blood sampling will be performed by finger-prick devices.
Time Frame
within a few days
Title
anti-transglutaminase autoantibodies (UA)
Description
Capillary blood sampling will be performed by finger-prick devices.
Time Frame
through study completion, an average of 1 year
Title
systolic and diastolic blood pressure (mmHg)
Description
Blood pressure measurement will be performed through a sphygmomanometer.
Time Frame
through study completion, an average of 1 year
Title
HbA1c (mmol/mol)
Description
Glycated hemoglobin will be measured by finger-prick devices.
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emanuele Bosi, MD
Phone
+390226432818
Email
bosi.emanuele@hsr.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emanuele Bosi, MD
Organizational Affiliation
San Raffaele Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scuola dell'Infanzia Comunale Don Angelo Luzzini
City
Cantalupo
State/Province
Milan
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
emanuele bosi
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34458905
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.
Results Reference
background
PubMed Identifier
30745054
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.
Results Reference
background
PubMed Identifier
31990315
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.
Results Reference
background
PubMed Identifier
28350936
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.
Results Reference
background
Learn more about this trial
Universal Capillary Screening for Chronic Autoimmune, Metabolic and Cardiovascular Diseases: Feasibility and Acceptability Pilot Study.
We'll reach out to this number within 24 hrs