Status:
RECRUITING
Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity
Lead Sponsor:
John Bauer
Conditions:
Obesity and Overweight
Obese Adolescents
Eligibility:
All Genders
12-17 years
Brief 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 ques...
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) depen...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 12 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06967389
Start Date
June 12 2025
End Date
July 1 2027
Last Update
July 4 2025
Active Locations (1)
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1
University of Kentucky
Lexington, Kentucky, United States, 40506