Study to Investigate Genetic Causes of Severe Early Childhood Onset Obesity. (GECO)

Columbia University

Status: Enrolling

Conditions: Obesity

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01998750

AAAR0351

P00009351 (Other Identifier)

5K23DK110539-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study aims to investigate genetic causes of early childhood obesity.

The investigators will enroll children and adults with severe early onset obesity (BMI > 99th percentile) diagnosed prior to 6 years of age. The investigators will ask questions about the health and eating behavior of the participants, and perform a brief physical examination. The investigators will collect saliva or blood to perform genetic testing from the participants and invite family members to enroll in the study.

Full description

This is a clinical and genomic study designed to investigate monogenic causes of severe early childhood obesity.

Participants with severe early onset obesity will be identified by screening of the clinical database or referred for the study. These subjects will be invited to participate in the study. After obtaining informed consent, the investigators will obtain history on the proband and the family, and perform a brief examination in addition to collecting genetic material.

Targeted sequencing of genes associated with monogenic and syndromic forms of obesity will be performed using next-generation sequencing. In selected individuals with favorable family history, exome or whole genome sequencing will be performed. Functional analysis of newly identified variants will be performed where possible.

Enrollment: 500 estimated patients

Sex: All

Ages: Under 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

- BMI > 99th percentile documented at age < 6 years of age

Exclusion criteria

• Known genetic causes of obesity
• Known Endocrine causes of obesity.
• Neurologic tumor, trauma or surgery
• Prior malignancy or transplant
• Known autoimmune diseases
• Edema of a known or unknown cause
• Prolonged steroid use.

Trial design

500 participants in 1 patient group

Early-onset severe obesity

Description:

The study will enroll individuals with early onset severe obesity (BMI \> 99th percentile noted at an age \< 6 years of age). Individuals with a known history of early onset obesity are eligible, regardless of their current age.