Study to Investigate Genetic Causes of Severe Early Childhood Onset Obesity. (GECO)
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|ClinicalTrials.gov Identifier: NCT01998750|
Recruitment Status : Recruiting
First Posted : December 2, 2013
Last Update Posted : July 14, 2020
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.
|Condition or disease|
This is a clinical and genomic study designed to investigate monogenic causes of severe early childhood obesity.
Participatns 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.
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Study to Identify Rare Genetic Variants Causing Severe Early Childhood Obesity|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||December 2025|
|Estimated Study Completion Date :||December 2030|
Early-onset severe obesity
The study will enroll children and young adults up to 21 years of age with early onset severe obesity (BMI > 99th percentile noted at an age < 6 years of age).
- Identification of known or novel genetic variants in genes that underlie obesity. [ Time Frame: 1.5-2 years ]Identification of known or novel genetic variants in genes that underlie obesity.
- Prevalence of melanocortin receptor 4 mutations. [ Time Frame: 2 years ]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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01998750
|Contact: Vidhu Thaker, M.D.||firstname.lastname@example.org|
|United States, New York|
|New York, New York, United States, 10032-3822|
|Contact: Vidhu Thaker, M.D. 212-851-5315 email@example.com|
|Principal Investigator: Vidhu Thaker, MD|
|Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Vidhu Thaker, MD 212-851-5315 firstname.lastname@example.org|
|Principal Investigator:||Vidhu Thaker, M.D.||Columbia University|