Childhood Onset ObesityVCORNCT02957916
Vanderbilt Childhood Obesity Registry
An observational study of Childhood Onset Obesity and Pediatric Obesity, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 100 years
- Conditions the study is for
- Childhood Onset Obesity, Pediatric Obesity, Childhood Obesity
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Dec 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Children with a history of excessive weight gain.
Who may be able to join
- BMI >97th percentile for age and gender before 6 years old
- Able to give written, informed consent/assent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Medical subject headings
- Pediatric Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of genetic mutations in DNA analysis
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startNov 2012
- Primary completionDec 2025
- Study completionDec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Onset ObesityStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashley Shoemaker, Vanderbilt University Medical Center
- Investigators
- Ashley Shoemaker, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02957916
- Sponsor's protocol ID
- 121345
- Acronym
- VCOR
- Status last verified
- Feb 2026
- First submitted
- 31 Oct 2016
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data will be shared with collaborators and on a case by case basis. Please contact Dr. Shoemaker for information.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vanderbilt Childhood Obesity Registry
- ClinicalTrials.gov ID
- NCT02957916
- Acronym / sponsor ID
- VCOR / 121345
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Nov 2012 (actual)
- Primary completion
- Dec 2025 (actual)
- Study completion
- Dec 2025 (actual)
- First posted
- 8 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 2 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children with a history of excessive weight gain.
Key inclusion criteria (2 listed)
- BMI >97th percentile for age and gender before 6 years old
- Able to give written, informed consent/assent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of genetic mutations in DNA analysis
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No. Data will be shared with collaborators and on a case by case basis. Please contact Dr. Shoemaker for information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashley Shoemaker, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Onset Obesity and Pediatric Obesity, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of genetic mutations in DNA analysis (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.