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

Diabetes Mellitus, Type 2 Clinical Trial

— DESCENDANCE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05567692
• Other study ID #: 2022-A01538-35
• Status: Recruiting
• Start date: February 10, 2023
• Est. completion date: October 1, 2032

Study information

• Verified date: January 2024
• Source: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
• Contact: Guillaume CHARPENTIER, Dr
• Phone: +33 1 64968654
• Email: kerbonac[@]free.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 837
• Est. completion date: October 1, 2032
• Est. primary completion date: October 1, 2032
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Diagnostic Test:
• OGTT
Oral Glucose Tolerance Test

Other:
• HbA1c
HbA1c measurement
• Questionnaire
Follow-up questionnaire

Locations

Country	Name	City	State
France	Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète	Évry

Sponsors (2)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Type 2 diabetes incidence in Descendance population	Presence of type 2 diabetes mellitus, on basis of self-reported (physician diagnosis) or diagnosed by OGTT and HbA1c	9years
Secondary	Provide estimates of prevalence of diabetes and prediabetes in Descendance population	To estimate the prevalence of undiagnosed diabetes mellitus and pre-diabetes in Descendance population	at baseline, 3-, 6- and 9-years follow-up
Secondary	Study of interactions between risk factors on type 2 diabetes incidence	Self-administered questionnaire. "Descendance" specific questionnaire	at baseline, 3-, 6- and 9-years follow-up