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临床试验/NCT05567692
NCT05567692暂停不适用

Descendance Cohort: Follow-up of Subjects With Type 2 Diabetes or at Risk of Type 2 Diabetes Defined by the Existence of the Disease in the Family in Two Successive Generations

Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète2 个研究点 分布在 1 个国家目标入组 837 人开始时间: 2023年2月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
暂停
发起方
入组人数
837
试验地点
2
主要终点
Type 2 diabetes incidence in Descendance population

研究概览

简要总结

The main objective of this study is to prospectively follow the subjects included in "Descendance" cohort and to describe the occurrence of type 2 diabetes in non-diabetic subjects, which will allow us to iteratively update the "Descendance" Type 2 Diabetes risk prediction model.

详细描述

High risk families will be prospectively follow in order to better understand the risk of transmission of type 2 diabetes from one generation to another. The cohort will also allow us to collect additional data on diabetic patients.

The monitoring of the cohort will take place for at least 10 years with a follow-up of all participants every three years. To detect individuals who develop dysglycemia during the study, a glucose tolerance test (GTT) and HbA1c measurement will be conducted.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects have participated in the Descendance study
  • Subjets who sign informed consent to participate in the study

排除标准

  • Subjects not enrolled in Descendance study
  • Subjects refusing to participate
  • Pregnant or breastfeeding
  • Subjects in emergency situations, under legal protection or unable to provide informed -consent
  • Subjects lost to follow-up or died

研究组 & 干预措施

T2D group

subjects with type 2 diabetes

干预措施: Questionnaire (Other)

Non-T2D group

healthy subjects

干预措施: OGTT (Diagnostic Test)

Non-T2D group

healthy subjects

干预措施: HbA1c (Other)

Non-T2D group

healthy subjects

干预措施: Questionnaire (Other)

结局指标

主要结局

Type 2 diabetes incidence in Descendance population

时间窗: 9years

Presence of type 2 diabetes mellitus, on basis of self-reported (physician diagnosis) or diagnosed by OGTT and HbA1c

次要结局

  • Provide estimates of prevalence of diabetes and prediabetes in Descendance population(at baseline, 3-, 6- and 9-years follow-up)
  • Study of interactions between risk factors on type 2 diabetes incidence(at baseline, 3-, 6- and 9-years follow-up)

研究者

发起方
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
申办方类型
Other
责任方
Sponsor

研究点 (2)

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