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

Mutation of the LEPR Gene at Reunion Island: Involvement in Pediatric Obesity GRÉOL (Génétique Réunion Obésité LEPR)

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.

Study Overview

• Status: Unknown
• Conditions: Obesity, Childhood

Detailed Description

The study of the deletion Δ6-8 of the LEPR gene starts with a saliva sample using a swab in children aged between 3 to 18 years old.

The DNA from this sample will then be analyzed by the PCR technique. If the deletion of the LEPR gene is confirmed in the patient, his adult family members will also be screened using the same procedure.

• Study Type: Observational
• Enrollment (Anticipated): 250

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of the Δ6-8 deletion of the LEPR gene in paediatric population	Presence of the deletion of the LEPR gene	at inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of the Δ6-8 deletion of the LEPR gene in adult family members	Presence of the deletion of the LEPR gene	6 months after inclusion of the paediatric population

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de la Réunion
• Investigators: Principal Investigator: Paul GUEGUEN, MD, CHU de la Réunion

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2021
• Primary Completion (ANTICIPATED): June 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: March 30, 2020
• First Submitted That Met QC Criteria: March 30, 2020
• First Posted (ACTUAL): April 1, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: 2019/CHU/04

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