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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
Sponsor:
Information provided by (Responsible Party):
Vidhu Thaker, Boston Children's Hospital

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
Obesity

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.

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Study Type : Observational
Estimated 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 : February 2014
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2030

Group/Cohort
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).



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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
Saliva or blood


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This study will enroll children with BMI > 99th percentile for age noted prior to 6 years of age. Current age of the child can vary from 0-21 years.
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Vidhu Thaker, M.D. 212-851-5315 vvt2114@cumc.columbia.edu

Locations
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United States, New York
Vidhu Thaker Recruiting
New York, New York, United States, 10032-3822
Contact: Vidhu Thaker, M.D.    212-851-5315    vidhu.thaker@childrens.harvard.edu   
Principal Investigator: Vidhu Thaker, MD         
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Vidhu Thaker, MD    212-851-5315    vvt2114@cumc.columbia.edu   
Sponsors and Collaborators
Boston Children's Hospital
Investigators
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Principal Investigator: Vidhu Thaker, M.D. Columbia University
Publications of Results:
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Responsible Party: Vidhu Thaker, Instructor in Pediatrics, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT01998750    
Other Study ID Numbers: IRB-P00009351
First Posted: December 2, 2013    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Deidentified data will be deposited in public databases at the end of the study
Keywords provided by Vidhu Thaker, Boston Children's Hospital:
obesity
genetics
early-onset
childhood
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight