Subjects With T2D or at Risk of T2D Cohort Follow-up

Active, not recruiting

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: Questionnaire; Diagnostic Test: OGTT; Other: HbA1c

• Registration Number: NCT05567692
• Lead Sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-09-22
• Study First Submitted QC: 2022-09-30
• Study First Posted: 2022-10-05
• Study Start: 2023-02-10
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-18
• Primary Completion: 2032-10-01
• Study Completion: 2032-10-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 837

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
T2D group	Questionnaire	subjects with type 2 diabetes
Non-T2D group	HbA1c	healthy subjects
Non-T2D group	Questionnaire	healthy subjects
Non-T2D group	OGTT	healthy subjects

Primary Outcome Measures

Name	Time	Method
Type 2 diabetes incidence in Descendance population	9years	Presence of type 2 diabetes mellitus, on basis of self-reported (physician diagnosis) or diagnosed by OGTT and HbA1c

Secondary Outcome Measures

Name	Time	Method
Provide estimates of prevalence of diabetes and prediabetes in Descendance population	at baseline, 3-, 6- and 9-years follow-up	To estimate the prevalence of undiagnosed diabetes mellitus and pre-diabetes in Descendance population
Study of interactions between risk factors on type 2 diabetes incidence	at baseline, 3-, 6- and 9-years follow-up	Self-administered questionnaire. "Descendance" specific questionnaire

Trial Locations

Locations (1)

Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète; 🇫🇷 Évry, France