Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-17
SponsorJohn Bauer

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Any current prescribed anti-obesity medications (AOM) such as Orlistat, Phentermine, Qsymia (Phentermine/Topiramate), Liraglutide, Semaglutide, and Setmelanotide

Any current prescribed anti-hypertensive medications

Any specific end-organ acute concerns (kidney disease, liver disease, congenital disease).

Any active infections at enrollment.

Trial design

Treatments tested in this trial

  • Ozempic®

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators

John Bauer

Lead sponsor

University of Kentucky

Sponsor institution