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

NCT05362565 | Unknown

• 1 other identifier: CHUBX 2021/55
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Monogenic Obesity

Keywords

monogenic obesity; pediatric; early onset obesity; genetic disease

Outcome Measures

Primary Outcomes (1)

• Positivity rate of patients for whom a diagnosis of monogenic obesity will be obtained when all analyses have been performed.

  Inclusion visit

Secondary Outcomes (2)

• Number of Patients eligible for a drug targeting single-gene obesity

  Inclusion visit

• Number of patients for whom a genetic finding will have changed management and description of changes.

  Inclusion visit

Study Arms (1)

Patient with salivary sampling

Biological: Salivary Sampling

Interventions

Salivary Sampling BIOLOGICAL

The DNA study will be carried out from saliva sample 1 saliva sample per patient will be performed at the inclusion visit

Patient with salivary sampling

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• no informed consent

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, 33400, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Salivary sampling

MeSH Terms

Conditions

Genetic Diseases, Inborn

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Louis LEBRETON

CONTACT

05 57 82 21 78; louis.lebreton@chu-bordeaux.fr

Wafae BELCADI

CONTACT

wafae.belcadi@chu-bordeaux.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 5, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: January 1, 2024
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)