VCOR: Vanderbilt Childhood Obesity Registry

• Sponsor: Vanderbilt University Medical Center (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02957916
• Collaborator: (none)
• Enrollment: 3,000
• Location: 1
• Duration (Months): 126.9
• Patients Per Site Per Month: 23.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Childhood Onset Obesity; Pediatric Obesity; Childhood 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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 3000 participants
• Observational Model: Other
• Time Perspective: Other
• Official Title: Vanderbilt Childhood Obesity Registry
• Study Start Date: Nov 1, 2012
• Anticipated Primary Completion Date: Nov 1, 2022
• Anticipated Study Completion Date: Jun 1, 2023

Outcome Measures

Primary Outcome Measures

1. Prevalence of genetic mutations in DNA analysis [5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt University	Nashville	Tennessee	United States	37232

Sponsors and Collaborators

• Vanderbilt University Medical Center

Investigators

• Principal Investigator: Ashley Shoemaker, MD, Vanderbilt University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ashley Shoemaker, MD, MSCI, Vanderbilt University Medical Center
• ClinicalTrials.gov Identifier: NCT02957916
• Other Study ID Numbers: 121345
• First Posted: Nov 8, 2016
• Last Update Posted: Jun 16, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Obesity; Pediatric Obesity

Study Results

No Results Posted as of Jun 16, 2022