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

NCT06113523 | Not Yet Recruiting

• 1 other identifier: CHUBX 2023/01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Non-syndromic monogenic obesity is a group of rare diseases characterized by severe and early onset obesity. Genetic characterization of these rare forms is important to target patients who may benefit from a personnalized care (new treatments, prognosis, adapted hygienic and dietary rules). This study aims to expand the diagnostic analysis from five to 71 genes and additionnaly to refine the causal role of some genes not widely tested in routine practice.

Conditions

Monogenic Obesity; Non Syndromic Obesity

Outcome Measures

Primary Outcomes (1)

• Positive rate of patients diagnosed with definite monogenic obesity

  Positive rate of patients diagnosed with definite monogenic obesity by genetic analysis with the 71 genes panel.

  inclusion visit

Study Arms (2)

Patient cohort

Patients already tested for monogenic obesity with the 71 genes panel.

Control cohort

Patients tested for other indication than monogenic obesity in the lab. The DNA samples will be sequenced for the 71 obesity genes especially for the study.

Biological: monogenic obesity

Interventions

monogenic obesity BIOLOGICAL

The DNA samples will be sequenced for the 71 obesity genes especially for the study.

Control cohort

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

* Patient cohort : Patients already tested for monogenic obesity with the 71 genes panel. * Control cohort : Patients tested for other indication than monogenic obesity in the lab. The DNA samples will be sequenced for the 71 obesity genes especially for the study.

You may qualify if:

• Body mass index above the International Obesity Task Force 30 curve by age 6.
• Consent for genetic testing signed with agreement to use secondary data for research purposes.

You may not qualify if:

• o For Control cohort :
• Body mass index under 25 kg/m2 after age 18 and no history of obesity.
• Signed consent for genetic testing with agreement to use biological samples and secondary data for research purposes.
• Opposition of the patient to the research - This opposition of the patient must be received by the investigator of the center within a maximum of 1 month after the sending of the information note.
• Degraded DNA

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, 33400, France

Location

Central Study Contacts

Louis LEBRETON, MD

CONTACT

+335 57 82 21 78; louis.lebreton@chu-bordeaux.fr

Study Design

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

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 2, 2023
• Study Start: February 1, 2024
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: November 2, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)