Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05841719
Status:
COMPLETED
Last Update Posted:
2024-03-06
First Post:
2023-02-03
Brief Title:
Universal Capillary Screening for Chronic Autoimmune Metabolic and Cardiovascular Diseases Feasibility and Acceptability Pilot Study
Sponsor:
Emanuele Bosi
Organization:
IRCCS San Raffaele
Study Overview
Official Title:
General Population Universal Capillary Screening for Chronic Autoimmune Metabolic and Cardiovascular Diseases UNISCREEN Feasibility and Acceptability Pilot Study
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UNISCREEN
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 complicationsThis 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 andor 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-2Tyrosine 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None