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Vanderbilt Childhood Obesity Registry (VCOR)

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ClinicalTrials.gov Identifier: NCT02957916
Recruitment Status : Recruiting
First Posted : November 8, 2016
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
Ashley Shoemaker, Vanderbilt University Medical Center

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
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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3000 participants
Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration: 1 Year
Official Title: Vanderbilt Childhood Obesity Registry
Study Start Date : November 2012
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : June 2021



Primary Outcome Measures :
  1. Prevalence of genetic mutations in DNA analysis [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA
DNA sample collected once in the form of either saliva or 5 mL of blood


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children with a history of excessive weight gain.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957916


Contacts
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Contact: Ashley Shoemaker, MD 6153438116 ashley.h.shoemaker@vanderbilt.edu

Locations
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United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Contact: Ashley Shoemaker, MD    615-343-8116    ashley.h.shoemaker@vanderbilt.edu   
Principal Investigator: Ashley Shoemaker, M.D.         
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Ashley Shoemaker, MD Vanderbilt University Medical Center

Additional Information:

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Responsible Party: Ashley Shoemaker, MD, MSCI, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT02957916     History of Changes
Other Study ID Numbers: 121345
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be shared with collaborators and on a case by case basis. Please contact Dr. Shoemaker for information.
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms