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Clinical Trials/NCT02957916
NCT02957916
Completed
N/A

Vanderbilt Childhood Obesity Registry

Vanderbilt University Medical Center1 site in 1 country3,000 target enrollmentNovember 1, 2012

Overview

Phase
N/A
Intervention
Not specified
Conditions
Childhood Onset Obesity
Sponsor
Vanderbilt University Medical Center
Enrollment
3000
Locations
1
Primary Endpoint
Prevalence of genetic mutations in DNA analysis
Status
Completed
Last Updated
2 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2012
End Date
December 1, 2025
Last Updated
2 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ashley Shoemaker

MD, MSCI

Vanderbilt University Medical Center

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Prevalence of genetic mutations in DNA analysis

Time Frame: 5 years

Study Sites (1)

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