Subjects With T2D or at Risk of T2D Cohort Follow-up | NCT05567692

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

NCT05567692

Sponsor

Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

Status

Suspended

Last Update Posted

May 15, 2026Actual

Enrollment

837Estimated

Phase

Not provided

Conditions

Diabetes Mellitus, Type 2

Interventions

OGTT
HbA1c
Questionnaire

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The sponsor has temporarily suspended study due to operational constraints.

Expanded Access Info

Start Date

Feb 10, 2023Actual

Primary Completion Date

Oct 1, 2032Estimated

Completion Date

Oct 1, 2032Estimated

First Submitted Date

Sep 22, 2022

First Submission Date that Met QC Criteria

Sep 30, 2022

First Posted Date

Oct 5, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2026

Last Update Posted Date

May 15, 2026Actual

Name	Class
Institut Pasteur de Lille	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

837Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
T2D group		subjects with type 2 diabetes	Other: Questionnaire
Non-T2D group		healthy subjects	Diagnostic Test: OGTT Other: HbA1c Other: Questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OGTT	Diagnostic Test	Oral Glucose Tolerance Test	Non-T2D group
HbA1c

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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
Study of interactions between risk factors on type 2 diabetes incidence

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Guillaume CHARPENTIER, Dr	Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète		Évry		91058	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005951	Glucose Tolerance Test
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D001774	Blood Chemical Analysis
D019963	Clinical Chemistry Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided