Clinical trial

Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity

Recruiting now · Not applicable · 1 countries · Registry ID NCT06967389

Recruiting nowNot applicableObservational

What this study 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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age12 Years to 17 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity and Overweight, Obese Adolescents, Weight Management, Weight Loss, Cardiovascular Disease Risk Factor

Full registry criteria

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)

Treatments and study arms

Ozempic®

Drug

The study medication will be given in accordance with standard of care dosing schedule.

Primary outcomes

Change in medication useEnrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

This will be assessed by reviewing changes in the electronic medical record

Change in Lipid ProfileEnrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

plasma/serum samples will be analyzed. blood lipid panel to include total cholesterol (mg/dL), HDL (mg/dL), triglycerides (mg/dL), and LDL (mg/dL) will be assessed

Change in C-reactive proteinEnrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment