Investigating genetic causes of severe obesity in young children
Study to Identify Rare Genetic Variants Causing Severe Early Childhood Obesity
This study is trying to find out if certain genes are linked to severe obesity in young children under six years old by looking at their health, eating habits, and family history.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | N/A to 80 Years |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT01998750 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the genetic factors contributing to severe early childhood obesity, specifically in children diagnosed before the age of six with a BMI above the 99th percentile. Participants, including both children and adults, will undergo a health and eating behavior assessment, a brief physical examination, and genetic testing through saliva or blood samples. Family members are also invited to participate to enhance the understanding of hereditary factors. The study will utilize next-generation sequencing to identify monogenic and syndromic causes of obesity.
Who should consider this trial
Good fit: Ideal candidates for this study are children diagnosed with severe early onset obesity before the age of six.
Not a fit: Patients with known genetic or endocrine causes of obesity, or those with certain medical histories such as prior malignancy or prolonged steroid use, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of severe early childhood obesity through genetic insights.
How similar studies have performed: Other studies investigating genetic causes of obesity have shown promise, indicating that this approach could yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts and 1 other locations
- Boston Children's Hospital — Boston, Massachusetts, United States (Active_not_recruiting)
- Columbia University Medical Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Vidhu Thaker, M.D. — Columbia University
- Study coordinator: Vidhu Thaker, M.D.
- Email: vvt2114@cumc.columbia.edu
- Phone: 212-851-5315
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.