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

NCT ID: NCT04329260

Last Updated: 2021-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-31

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obesity, Childhood

Study Design

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Observational Model Type

FAMILY_BASED

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de la Réunion

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul GUEGUEN, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de La Réunion

Central Contacts

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Emilie TECHER

Role: CONTACT

+262 262 90 62 89

Other Identifiers

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2019/CHU/04

Identifier Type: -

Identifier Source: org_study_id

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