Actively Recruiting
Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity
Led by John Bauer · Updated on 2025-07-04
50
Participants Needed
1
Research Sites
107 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Current use of prescribed anti-obesity medications such as Orlistat, Phentermine, Qsymia, Liraglutide, Semaglutide, or Setmelanotide
- Current use of prescribed anti-hypertensive medications
- Any acute end-organ concerns like kidney disease, liver disease, or congenital disease
- Active infections at enrollment
- Use of systemic steroids longer than 3 months or within the last month before enrollment (excluding inhaled, ophthalmic, intranasal, and topical steroids)
- Limitations preventing exercise testing
- Known congenital abnormalities or genetic syndromes associated with obesity
- Pregnancy
- Inability to receive an MRI
- Personal or family history of medullary thyroid carcinoma
- Diagnosis of Multiple Endocrine Neoplasia syndrome type 2
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Kentucky
Lexington, Kentucky, United States, 40506
Actively Recruiting
Research Team
M
Margaret Murphy, RD PhD
CONTACT
H
Heather Collins, BSN RN CCRP
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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