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Vanderbilt Childhood Obesity Registry

Vanderbilt Childhood Obesity Registry

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02957916
Acronym
VCOR
Enrollment
3000
Registered
2016-11-08
Start date
2012-11-01
Completion date
2025-12-01
Last updated
2026-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Obesity, Childhood Onset Obesity, Pediatric Obesity

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.

Interventions

None listed

Sponsors

Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
2 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Prevalence of genetic mutations in DNA analysis5 years

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAshley Shoemaker, MD

Vanderbilt University Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026