Mutation of the LEPR Gene at Reunion Island: Involvement in Pediatric Obesity

NCT04329260 | Unknown

• 1 other identifier: 2019/CHU/04
• Study Type: observational
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to estimate the proportion of the recurrent deletion Δ6-8 of the LEPR gene in the homozygous and heterozygous state in pediatric cases with severe and early ( before the age of 6) obesity (BMI ≥ IOTF-30) on Reunion Island.

Conditions

Obesity, Childhood

Outcome Measures

Primary Outcomes (1)

• Proportion of the Δ6-8 deletion of the LEPR gene in paediatric population

  Presence of the deletion of the LEPR gene

  at inclusion

Secondary Outcomes (1)

• Proportion of the Δ6-8 deletion of the LEPR gene in adult family members

  6 months after inclusion of the paediatric population

Study Arms (2)

Pediatric population

Children between 3 to 18 years old with severe (BMI\> IOTF-30) and early (before the age of 6) obesity. A Saliva sample for screening of the deletion Δ6-8 of LEPR gene will be performed for each child.

Adult member family

The screening of the same deletion according the same procedure will be proposed to the adult family member if the child presents the deletion Δ6-8 of LEPR gene.

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children between 3 to 18 years old with severe obesity (BMI\>30) and adult family members.

You may qualify if:

• patient with early severe and non syndromic obesity (BMI\> IOTC-30) (before 6 years old)
• adult family members with deletion of LEPR gene
• informed consent form signed by participants or parents
• affiliation to social security scheme

You may not qualify if:

• patient with syndromic obesity
• patient Under guardianship or Under judicial protection

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Réunion: lead

Biospecimen

Retention: SAMPLES WITH DNA

saliva sample

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul GUEGUEN, MD

  CHU de La Réunion

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilie TECHER

CONTACT

+262 262 90 62 89; emilie.techer@chu-reunion.fr

Study Design

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

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 1, 2020
• Study Start: March 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share