Obesity, ChildhoodGDOPNCT05747976
Genetic Disorders of Obesity Program Database
An observational study of Obesity, Childhood and Genetic Disease, run by Baylor College of Medicine at 1 site in United States.
Trial summary
This study collects data on children with severe, early-onset obesity. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Obesity, Childhood, Genetic Disease
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2020to 31 Dec 2030
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Children with early-onset, severe obesity.
Who may be able to join
- For individuals 2 years and older, BMI > 97 percentile
- For individuals < 2 years old, weight-to-length ratio > 95th percentile
Who cannot join
- No other exclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Citrine Elatrash, citrine.elatrash@bcm.edu
Stephanie Sisley, MD
About this study
This study collects data on children with severe, early-onset obesity.
Read the detailed description
Children and adolescents who have suffered from severe weight gain prior to 5 years of age and who are seen in the Genetic Disorders of Obesity Program at Texas Children are asked to participate in a prospective, observational study. The investigators collect demographic information, body measurements, medical/family history, as well as other questionnaires. Additionally, genetic information, medical lab results, and responses to treatment options are collected. The goal of the study is to determine if the investigators can better understand which children would benefit from testing and further workup as well as to understand how obesity develops in these children and adolescents.
- Conditions
- Obesity, Childhood, Genetic Disease
- Medical subject headings
- Pediatric Obesity, Genetic Diseases, Inborn
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of genetic causes of severe, early-onset obesity
We will measure the number of genetic variants identified in clinical testing
Measured: through study completion, an average of 10 years
Secondary outcomes (1)
Change in BMI over time
BMI in kg/m2 will be documented over time. BMI is calculated using weight and height
Measured: through participant completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start30 Aug 2020
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Sisley, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747976
- Sponsor's protocol ID
- H-44596
- Acronym
- GDOP
- Status last verified
- May 2026
- First submitted
- 11 Nov 2022
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Disorders of Obesity Program Database
- ClinicalTrials.gov ID
- NCT05747976
- Acronym / sponsor ID
- GDOP / H-44596
- Conditions
- Obesity, Childhood, Genetic Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 30 Aug 2020 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 28 Feb 2023 (actual)
- 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.
This study collects data on children with severe, early-onset obesity.
Detailed description
Children and adolescents who have suffered from severe weight gain prior to 5 years of age and who are seen in the Genetic Disorders of Obesity Program at Texas Children are asked to participate in a prospective, observational study. The investigators collect demographic information, body measurements, medical/family history, as well as other questionnaires. Additionally, genetic information, medical lab results, and responses to treatment options are collected. The goal of the study is to determine if the investigators can better understand which children would benefit from testing and further workup as well as to understand how obesity develops in these children and adolescents.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children with early-onset, severe obesity.
Key inclusion criteria (2 listed)
- For individuals 2 years and older, BMI > 97 percentile
- For individuals < 2 years old, weight-to-length ratio > 95th percentile
Key exclusion criteria (1 listed)
- No other exclusion criteria
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 causes of severe, early-onset obesity
Time frame: through study completion, an average of 10 years
We will measure the number of genetic variants identified in clinical testing
1 secondary outcome
Change in BMI over time
Time frame: through participant completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No
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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.
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 Obesity, Childhood and Genetic Disease, run by Baylor College of Medicine 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 1 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: looking for participants now, as of the sponsor's last update on 12 May 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Sisley, MD (713-798-0391, Sisley.lab@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of genetic causes of severe, early-onset obesity (time frame: through study completion, an average of 10 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 12 May 2026.