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

Sponsor
Boston Children's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT01998750
Collaborator
(none)
500
Enrollment
2
Locations
202
Duration (Months)
250
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Study to Identify Rare Genetic Variants Causing Severe Early Childhood Obesity
    Study Start Date :
    Feb 1, 2014
    Anticipated Primary Completion Date :
    Dec 1, 2025
    Anticipated Study Completion Date :
    Dec 1, 2030

    Arms and Interventions

    Arm Intervention/Treatment
    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).

    Outcome Measures

    Primary Outcome Measures

    1. Identification of known or novel genetic variants in genes that underlie obesity. [1.5-2 years]

      Identification of known or novel genetic variants in genes that underlie obesity.

    Secondary Outcome Measures

    1. Prevalence of melanocortin receptor 4 mutations. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 21 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vidhu Thaker New York New York United States 10032-3822
    2 Columbia University Medical Center New York New York United States 10032

    Sponsors and Collaborators

    • Boston Children's Hospital

    Investigators

    • Principal Investigator: Vidhu Thaker, M.D., Columbia University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vidhu Thaker, Instructor in Pediatrics, Boston Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT01998750
    Other Study ID Numbers:
    • IRB-P00009351
    First Posted:
    Dec 2, 2013
    Last Update Posted:
    Oct 31, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Vidhu Thaker, Instructor in Pediatrics, Boston Children's Hospital
    obesity
    genetics
    early-onset
    childhood
    Additional relevant MeSH terms:
    Obesity

    Study Results

    No Results Posted as of Oct 31, 2022