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

• Sponsor: University Hospital, Bordeaux (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05362565
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 15
• Patients Per Site Per Month: 6.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Monogenic Obesity	Biological: Salivary Sampling

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Genetic Research of Monogenic Obesity in a Pediatric Cohort With Severe and Early Onset Obesity
• Anticipated Study Start Date: Oct 1, 2022
• Anticipated Primary Completion Date: Oct 1, 2023
• Anticipated Study Completion Date: Jan 1, 2024

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Positivity rate of patients for whom a diagnosis of monogenic obesity will be obtained when all analyses have been performed. [Inclusion visit]

Secondary Outcome Measures

1. Number of Patients eligible for a drug targeting single-gene obesity [Inclusion visit]

2. Number of patients for whom a genetic finding will have changed management and description of changes. [Inclusion visit]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Universitaire de Bordeaux	Bordeaux		France	33400

Sponsors and Collaborators

• University Hospital, Bordeaux

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Bordeaux
• ClinicalTrials.gov Identifier: NCT05362565
• Other Study ID Numbers: CHUBX 2021/55
• First Posted: May 5, 2022
• Last Update Posted: May 5, 2022
• Last Verified: May 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 University Hospital, Bordeaux: monogenic obesity; pediatric; early onset obesity; genetic disease
• Additional relevant MeSH terms: Obesity

Study Results

No Results Posted as of May 5, 2022