Recruiting

Genetic Causes

Sponsor:

Columbia University

Code:

NCT01998750

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

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.

Conditions

Obesity

Study ID

NCT01998750

Start date

Feb, 2014

Status verified date

Oct, 2025

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Identification of known or novel genetic variants in genes that underlie obesity. [ Time Frame: 1.5-2 years ]

Central Contacts and Locations

Central contacts

Vidhu Thaker, M.D.

212-851-5315vvt2114@cumc.columbia.edu

Locations

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Vidhu Thaker, MD

212-851-5315vvt2114@cumc.columbia.edu

More Information

Sponsor

Columbia University

Last update posted

Oct 21, 2025

Last verified

Oct, 2025

Keywords

  • obesity
  • genetics
  • early-onset
  • childhood

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2025-10-21.