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

Obesity, Childhood Clinical Trial

— GREOL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04329260
• Other study ID #: 2019/CHU/04
• Status: Not yet recruiting
• Start date: March 2021
• Est. completion date: December 2022

Study information

• Verified date: January 2021
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: Emilie TECHER
• Phone: +262 262 90 62 89
• Email: emilie.techer[@]chu-reunion.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: December 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Obesity, Childhood
• Pediatric Obesity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of the ?6-8 deletion of the LEPR gene in paediatric population	Presence of the deletion of the LEPR gene	at inclusion
Secondary	Proportion of the ?6-8 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