Study to Investigate Genetic Causes of Severe Early Childhood Onset Obesity.
NCT ID: NCT01998750
Last Updated: 2025-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2014-02-28
2030-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Early-onset severe obesity
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
80 Years
ALL
No
Sponsors
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Boston Children's Hospital
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Columbia University
OTHER
Responsible Party
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Vidhu V. Thaker
Assistant Professor
Principal Investigators
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Vidhu Thaker, M.D.
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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Boston Children's Hospital
Boston, Massachusetts, United States
Columbia University Medical Center
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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 Severe Early-Onset Obesity. J Clin Endocrinol Metab. 2019 Jul 1;104(7):2961-2970. doi: 10.1210/jc.2018-02657.
Other Identifiers
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P00009351
Identifier Type: OTHER
Identifier Source: secondary_id
AAAR0351
Identifier Type: -
Identifier Source: org_study_id
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