Vanderbilt Childhood Obesity Registry

Active, not recruiting

• Conditions: Childhood Obesity; Childhood Onset Obesity; Pediatric Obesity

• Registration Number: NCT02957916
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

In order to better understand early onset obesity and to identify patients in interested in future research studies, including clinical trials, we aim to develop a registry for patients with early onset obesity.

Detailed Description

Obesity is an epidemic effecting the pediatric population. Currently, 17% of children are classified as obese and 32% as overweight. Many of these children develop complications including type 2 diabetes, dyslipidemia, hypertension and hepatic steatosis. Obesity is a global epidemic that lacks effective treatment options. Obesity has many underlying causes including genetic predisposition and environmental factors. Understanding the genetic basis of obesity may allow for more precisely targeted interventions including specific dietary plans and pharmacologic treatments. The most common cause of genetic obesity is haploinsufficiency of the melanocortin-4 receptor (MC4R). In obese adult cohorts, the prevalence of pathogenic MC4R mutations is 1-2%. Commercial testing is available for many obesity syndromes, but the cost is high and charges are not always covered by insurance. Clinicians have little motivation to test patients for MC4R mutations as no treatments are available and it is not clear if genetic testing results change patient behavior. This particular lab and other groups are working to develop novel pharmacologic treatments for obesity syndromes, such as MC4R deficiency. In order to better understand early onset obesity and to identify patients in interested in future research studies, including clinical trials, the investigators aim to develop a registry for patients with early onset obesity.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2016-10-31
• Study First Submitted QC: 2016-11-04
• Study First Posted: 2016-11-08
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-12
• Primary Completion: 2032-01
• Study Completion: 2032-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

1. BMI >97th percentile for age and gender before 6 years old
2. Able to give written, informed consent/assent

Exclusion Criteria

1. Diagnosis of Prader-Willi syndrome
2. Use of exogenous steroids or other medications known to cause abnormal weight gain
3. Cushing's syndrome, untreated growth hormone deficiency or untreated hypothyroidism as an etiology for the obesity
4. Hypothalamic obesity (obesity due to a brain tumor, head trauma or other brain lesion)
5. Currently pregnant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of genetic mutations in DNA analysis	5 years

Trial Locations

Locations (1)

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States