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

Obesity Clinical Trial

— GECO  

Official title:

Study to Identify Rare Genetic Variants Causing Severe Early Childhood Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01998750
• Other study ID #: IRB-P00009351
• Status: Recruiting
• Start date: February 2014
• Est. completion date: December 2030

Study information

• Verified date: August 2023
• Source: Columbia University
• Contact: Vidhu Thaker, M.D.
• Phone: 212-851-5315
• Email: vvt2114[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

The investigators will enroll children and young 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2030
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York
United States	Vidhu Thaker	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Boston Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

De Rosa MC, Chesi A, McCormack S, Zhou J, Weaver B, McDonald M, Christensen S, Liimatta K, Rosenbaum M, Hakonarson H, Doege CA, Grant SFA, Hirschhorn JN, Thaker VV. Characterization of Rare Variants in MC4R in African American and Latino Children With Sev — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of known or novel genetic variants in genes that underlie obesity.	Identification of known or novel genetic variants in genes that underlie obesity.	1.5-2 years
Secondary	Prevalence of melanocortin receptor 4 mutations.	We will test the hypothesis that 1-3% of early onset obesity could be explained by carriage of mutation of monogenic obesity such as melanocortin receptor 4 in a mixed pediatric population.	2 years