Autoimmune Diseases, Cardiovascular Risk Factors
Conditions
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.
Interventions
OTHERScreening test
Capillary blood sampling by finger-prick devices and second confirmatory venous sampling when needed.
Sponsors
Italian Diabetes Foundation
Emanuele Bosi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
capillary sampling
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| feasibility and acceptability | through study completion, an average of 1 year | To assess feasibility and acceptability of the screening program |
| blood glucose and lipids level (mg/dl) | through study completion, an average of 1 year | Capillary blood sampling will be performed by finger-prick devices. |
| IAA, GADA65, ZnT8, IA2 autoantibodies (U/ml) | within a few days | Capillary blood sampling will be performed by finger-prick devices. |
| anti-transglutaminase autoantibodies (UA) | through study completion, an average of 1 year | Capillary blood sampling will be performed by finger-prick devices. |
| systolic and diastolic blood pressure (mmHg) | through study completion, an average of 1 year | Blood pressure measurement will be performed through a sphygmomanometer. |
| HbA1c (mmol/mol) | through study completion, an average of 1 year | Glycated hemoglobin will be measured by finger-prick devices. |
Countries
Italy
Outcome results
None listed