Vanderbilt Childhood Obesity Registry

Childhood Obesity Clinical Trial

— VCOR  

Official title:

Vanderbilt Childhood Obesity Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02957916
• Other study ID #: 121345
• Status: Active, not recruiting
• Start date: November 2012
• Est. completion date: January 2032

Study information

• Verified date: March 2024
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3000
• Est. completion date: January 2032
• Est. primary completion date: January 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Childhood Obesity
• Childhood Onset Obesity
• Obesity
• Pediatric Obesity

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of genetic mutations in DNA analysis		5 years