Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity
Purpose
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
Conditions
- Obesity and Overweight
- Obese Adolescents
- Weight Management
- Weight Loss
- Cardiovascular Disease Risk Factor
Eligibility
- Eligible Ages
- Between 12 Years and 17 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
Exclusion Criteria
- 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. - Any systemic steroid use longer than 3 month use or within the last month before enrollment (not including inhaled, ophthalmic, intranasal, and topical). - Any limitations that would make exercise testing not possible. - Any congenital abnormality or genetic syndrome known to be associated with obesity - Pregnancy - Inability to receive an MRI - Personal or family history of medullary thyroid carcinoma (per product insert) - Patients with Multiple Endocrine Neoplasia syndrome type 2 (per product insert)
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Treatment Group | All participants in this study will be given the study drug. |
|
Recruiting Locations
UK Center for Clinical and Translational Science and nearby locations
Lexington, Kentucky 40506
More Details
- NCT ID
- NCT06967389
- Status
- Recruiting
- Sponsor
- John Bauer
Detailed Description
This is an observational study in which all participants will be given semaglutide. There will be no randomization and no placebo. Participants will be in the study for 12 months (+/- 2 months) depending on when they reach the maintenance dose of semaglutide. Blood and urine will be maintained by the principal investigator indefinitely. Identifiers will be removed from the samples. Approximately 50 patients will be enrolled. The study drug, Ozempic, is FDA approved.