Genetic Disorders of Obesity Program Database

Obesity, Childhood Clinical Trial

— GDOP  

Official title:

Genetic Disorders of Obesity Program Database

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05747976
• Other study ID #: H-44596
• Status: Recruiting
• Start date: August 30, 2020
• Est. completion date: December 31, 2030

Study information

• Verified date: March 2024
• Source: Baylor College of Medicine
• Contact: Stephanie Sisley, MD
• Phone: 713-798-0391
• Email: Sisley.lab[@]bcm.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study collects data on children with severe, early-onset obesity.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Genetic Disease
• Genetic Diseases, Inborn
• Obesity
• Obesity, Childhood
• Pediatric Obesity

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of genetic causes of severe, early-onset obesity	We will measure the number of genetic variants identified in clinical testing	through study completion, an average of 10 years
Secondary	Change in BMI over time	BMI in kg/m2 will be documented over time. BMI is calculated using weight and height	through participant completion, an average of 2 years