Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity (MODERN)

University of Kentucky

Status: Not yet enrolling

Conditions: Weight Loss; Obesity and Overweight; Obese Adolescents; Cardiovascular Disease Risk Factor; Weight Management

Treatments: Drug: Ozempic®

Study type: Observational

Funder types: Other

Identifiers

NCT06967389

98420

Details and patient eligibility

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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)

Trial design

50 participants in 1 patient group

Treatment Group

Description:

All participants in this study will be given the study drug.

Treatment:

Drug: Ozempic®