跳至主要内容
临床试验/NCT05841719
NCT05841719已完成不适用

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

Emanuele Bosi1 个研究点 分布在 1 个国家目标入组 1,535 人开始时间: 2023年4月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,535
试验地点
1
主要终点
feasibility and acceptability

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

feasibility and acceptability

时间窗: through study completion, an average of 1 year

To assess feasibility and acceptability of the screening program

systolic and diastolic blood pressure (mmHg)

时间窗: through study completion, an average of 1 year

Blood pressure measurement will be performed through a sphygmomanometer.

HbA1c (mmol/mol)

时间窗: through study completion, an average of 1 year

Glycated hemoglobin will be measured by finger-prick devices.

blood glucose and lipids level (mg/dl)

时间窗: 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)

时间窗: within a few days

Capillary blood sampling will be performed by finger-prick devices.

anti-transglutaminase autoantibodies (UA)

时间窗: through study completion, an average of 1 year

Capillary blood sampling will be performed by finger-prick devices.

次要结局

未报告次要终点

研究者

发起方
Emanuele Bosi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Emanuele Bosi

MD, Professor of Internal Medicine, Head, General Medicine, Diabetes & Endocrinology

IRCCS San Raffaele

研究点 (1)

Loading locations...

相似试验