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Genetic Disorders of Obesity Program Database (GDOP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05747976
Recruitment Status : Recruiting
First Posted : February 28, 2023
Last Update Posted : February 28, 2023
Sponsor:
Information provided by (Responsible Party):
Stephanie Sisley, Baylor College of Medicine

Study Description
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Brief Summary:
This study collects data on children with severe, early-onset obesity.

Condition or disease
Obesity, Childhood Genetic Disease

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
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Genetic Disorders of Obesity Program Database
Actual Study Start Date : August 30, 2020
Estimated Primary Completion Date : December 31, 2030
Estimated Study Completion Date : December 31, 2030
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change in BMI over time [ Time Frame: through participant completion, an average of 2 years ]
    BMI in kg/m2 will be documented over time. BMI is calculated using weight and height


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children with early-onset, severe obesity.
Criteria

Inclusion Criteria:

  • For individuals 2 years and older, BMI > 97 percentile
  • For individuals < 2 years old, weight-to-length ratio > 95th percentile

Exclusion Criteria:

  • No other exclusion criteria
Contacts and Locations
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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): NCT05747976


Contacts
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Contact: Stephanie Sisley, MD 713-798-0391 Sisley.lab@bcm.edu

Locations
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United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Citrine Elatrash       citrine.elatrash@bcm.edu   
Principal Investigator: Stephanie Sisley, MD         
Sponsors and Collaborators
Baylor College of Medicine
More Information
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Responsible Party: Stephanie Sisley, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT05747976    
Other Study ID Numbers: GDOP Registry
First Posted: February 28, 2023    Key Record Dates
Last Update Posted: February 28, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Genetic Diseases, Inborn
Obesity
Pediatric Obesity
Overweight
 Overnutrition
Nutrition Disorders
Body Weight