Clinical trial NCT02957916: Vanderbilt Childhood Obesity Registry
Official title: Vanderbilt Childhood Obesity Registry
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Childhood Onset Obesity
Pediatric Obesity
Childhood Obesity
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2016-11-08
Enrollment: 3000
Sex: ALL
Minimum age (years): 2
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with a history of excessive weight gain.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of genetic mutations in DNA analysis
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Ashley Shoemaker, MD
role: PRINCIPAL_INVESTIGATOR
References: