Actively Recruiting
Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity (MODERN)
Led by John Bauer · Updated on 2025-07-04
50
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether the drug semaglutide affects health risk markers related to weight in children aged 12 to 15 years who have severe obesity (class 2 or 3). The study aims to understand how weight loss, body measurements, heart function, and exercise ability relate to each other at the start, and how these factors and disease risk markers change over time with semaglutide treatment. It also looks for differences between males and females to identify factors that may improve outcomes. All participants will receive semaglutide following the standard dosing schedule, with no placebo or randomization. The study lasts about 12 months, depending on when participants reach their maintenance dose. During this time, participants will have two heart scans (MRI or echocardiogram), body composition and fitness assessments, and urine tests. Blood samples will be collected at the start, around 6 months, and at the end of the study during routine lab draws. Participants will have follow-up visits with the study doctor and may be asked to take pregnancy tests if female and menstruating. Researchers will track changes in medication use, blood pressure, heart structure and function, inflammation markers, body measurements, diet, exercise habits, and mental health questionnaires. Blood and urine samples will be stored indefinitely without identifiers. The total participation duration is about 12 months with detailed monitoring throughout.
CONDITIONS
Brief 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 any prescribed anti-obesity medications such as Orlistat, Phentermine, Qsymia, Liraglutide, Semaglutide, or Setmelanotide
- Current use of any prescribed anti-hypertensive medications
- Presence of acute end-organ concerns such as kidney disease, liver disease, or congenital disease
- Active infections at enrollment
- Systemic steroid use longer than 3 months or within the last month before enrollment (excluding inhaled, ophthalmic, intranasal, and topical steroids)
- Limitations that prevent exercise testing
- Known congenital abnormalities or genetic syndromes associated with obesity
- Pregnancy
- Inability to undergo MRI
- Personal or family history of medullary thyroid carcinoma
- Diagnosis of Multiple Endocrine Neoplasia syndrome type 2
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months (+/- 2 months)
Participants receive the study medication Ozempic® according to a standard dosing schedule as part of their care.
Visits at enrollment, 6 months, and 12 months (+/- 2 months)
Duration - Indefinite
Participants' blood and urine samples are stored indefinitely for ongoing analysis without personal identifiers.
Ongoing sample collection as part of study procedures
Trial Site Locations
Total: 1 location
1
University of Kentucky
Lexington, Kentucky, United States, 40506
Actively Recruiting
Research Team
M
Margaret Murphy, RD PhD
H
Heather Collins, BSN RN CCRP
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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