- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05567692
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
-
Évry, France, 91058
- Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Collaborators
Investigators
- Principal Investigator: Guillaume CHARPENTIER, Dr, Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Metabolic Diseases
- Glucose Metabolism Disorders
- Diabetes Mellitus
- Nutritional and Metabolic Diseases
- Diabetes Mellitus, Type 2
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Blood Chemical Analysis
- Clinical Chemistry Tests
- Diagnostic Techniques, Endocrine
- Surveys and Questionnaires
- Glucose Tolerance Test
Other Study ID Numbers
- 2022-A01538-35
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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