Subjects With T2D or at Risk of T2D Cohort Follow-up (DESCENDANCE)

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

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.

Study Overview

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 Type

Observational

Enrollment (Estimated)

837

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Évry, France, 91058
        • Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All subjects included in the DESCENDANCE clinical trial (Id: NCT01727349) between 20011 and 2020, will be re-invited to participate in the Descendance cohort follow-up.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
T2D group
subjects with type 2 diabetes
Follow-up questionnaire
Non-T2D group
healthy subjects
Follow-up questionnaire
Oral Glucose Tolerance Test
HbA1c measurement

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Guillaume CHARPENTIER, Dr, Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2023

Primary Completion (Estimated)

October 1, 2032

Study Completion (Estimated)

October 1, 2032

Study Registration Dates

First Submitted

September 22, 2022

First Submitted That Met QC Criteria

September 30, 2022

First Posted (Actual)

October 5, 2022

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

April 1, 2026

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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