Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity (MODERN)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

The goal of this clinical trial is to learn if the drug semaglutide changes markers of disease risk as it relates to weight in children ages 12-15 years old who are obese (class 2 or 3). The main questions it aims to answer are: * How do the rate of weight loss, body mass index (BMI), body composition, heart structure and function, and exercise ability interact with one another in the study population at enrollment? * How do risk markers of disease change over the study in the study participants who are given semaglutides to help with weight loss? * Are there differences in the above factors between males and females and are there key factors to help improve the outcomes? Participants will be given semaglutide for this study. During the course of the study, participants will: * have two cardiac MRI scans OR two cardiac echocardiograms (one before starting semaglutide and one around 12 months after taking the drug) * have body composition and fitness levels assessed twice (before semaglutide and around 12 months after taking it) and have urine specific gravity (USG) measured * have extra blood drawn when labs their doctor orders are already being drawn (once at the beginning of the study, once around 6 months after enrollment, and once at the end of the study) * have follow up visits with the study doctor * be asked to take a pregnancy test if they are female and have started menstruation

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 17
Healthy Volunteers: f
View:

• Patient seen at University of Kentucky Pediatric High BMI Clinic

• Diagnosis of Obesity Class 2 or 3

• Meeting the clinical criteria for the medical intervention with semaglutide for weight loss

Locations
United States
Kentucky
University of Kentucky
RECRUITING
Lexington
Contact Information
Primary
Margaret Murphy, RD PhD
maggie.murphy@uky.edu
859-323-2969
Backup
Heather Collins, BSN RN CCRP
heather.collins1@uky.edu
859-562-1103
Time Frame
Start Date: 2025-06-12
Estimated Completion Date: 2027-07
Participants
Target number of participants: 50
Treatments
Treatment Group
All participants in this study will be given the study drug.
Related Therapeutic Areas
Sponsors
Leads: John Bauer

This content was sourced from clinicaltrials.gov