Genetic Research of Monogenic Obesity in a Pediatric Cohort With Severe and Early Onset Obesity (OBEGENE)

May 2, 2022 updated by: University Hospital, Bordeaux
Obesity is a frequent disease mainly caused by environmental/polygenic factors and more rarely caused by the alteration of a single gene ("monogenic obesity"). The diagnosis of these rare forms can lead to personalized management (new treatments, prognosis, adapted hygienic and dietary rules) and family screening. The use of a panel covering the known causes of monogenic obesity on a pediatric cohort of severe and early obesity will allow to evaluate the relevance of these analyses to adapt the management of this type of patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

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

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with a Body mass index, greater than the International Obesity Task Force (IOTF) 30 curve before the age of 5.

Description

Inclusion Criteria:

  • Recruitment age: 2-17 years
  • Body mass index, greater than the International Obesity Task Force (IOTF) 30 curve before the age of 5
  • Care at the specialized pediatric obesity center (CSO) of the Bordeaux University Hospital
  • Informed consent signed

Exclusion Criteria:

  • no informed consent

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient with salivary sampling
Biological: Salivary Sampling

The DNA study will be carried out from saliva sample

1 saliva sample per patient will be performed at the inclusion visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Positivity rate of patients for whom a diagnosis of monogenic obesity will be obtained when all analyses have been performed.
Time Frame: Inclusion visit
Inclusion visit

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Patients eligible for a drug targeting single-gene obesity
Time Frame: Inclusion visit
Inclusion visit
Number of patients for whom a genetic finding will have changed management and description of changes.
Time Frame: Inclusion visit
Inclusion visit

Collaborators and Investigators

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

Sponsor

University Hospital, Bordeaux

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 (Anticipated)

October 1, 2022

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

May 2, 2022

First Submitted That Met QC Criteria

May 2, 2022

First Posted (Actual)

May 5, 2022

Study Record Updates

Last Update Posted (Actual)

May 5, 2022

Last Update Submitted That Met QC Criteria

May 2, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2021/55

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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