Genetic Disorders of Obesity Program Database

Recruiting

• Conditions: Genetic Disease; Obesity, Childhood

• Registration Number: NCT05747976
• Lead Sponsor: Baylor College of Medicine

Brief Summary

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 Timeline

• Study Start: 2020-08-30
• Study First Submitted: 2022-11-11
• Study First Submitted QC: 2023-02-27
• Study First Posted: 2023-02-28
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-20
• Primary Completion: 2030-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

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

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Exclusion Criteria

• No other exclusion criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of genetic causes of severe, early-onset obesity	through study completion, an average of 10 years	We will measure the number of genetic variants identified in clinical testing

Secondary Outcome Measures

Name	Time	Method
Change in BMI over time	through participant completion, an average of 2 years	BMI in kg/m2 will be documented over time. BMI is calculated using weight and height

Trial Locations

Locations (1)

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States