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

Sponsor
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05567692
Collaborator
Institut Pasteur de Lille (Other)
837
1
117
7.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: OGTT
  • Other: HbA1c
  • Other: Questionnaire

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 Design

Study Type:
Observational
Anticipated Enrollment :
837 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
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
Anticipated Study Start Date :
Jan 2, 2023
Anticipated Primary Completion Date :
Oct 1, 2032
Anticipated Study Completion Date :
Oct 1, 2032

Arms and Interventions

Arm Intervention/Treatment
T2D group

subjects with type 2 diabetes

Other: Questionnaire
Follow-up questionnaire

Non-T2D group

healthy subjects

Diagnostic Test: OGTT
Oral Glucose Tolerance Test

Other: HbA1c
HbA1c measurement

Other: Questionnaire
Follow-up questionnaire

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète Évry France 91058

Sponsors and Collaborators

  • Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
  • Institut Pasteur de Lille

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
ClinicalTrials.gov Identifier:
NCT05567692
Other Study ID Numbers:
  • 2022-A01538-35
First Posted:
Oct 5, 2022
Last Update Posted:
Dec 27, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 27, 2022