Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity

Official title

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

Overview

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

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) 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.

Interventions

• Drug Ozempic®
  The study medication will be given in accordance with standard of care dosing schedule.

Primary outcome measures

• Change in medication use [Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
• Change in Lipid Profile [Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
• Change in C-reactive protein [Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
• Change in Tumor necrosis factor [Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
• Change in Interleukin-6 [Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
• Change in Adiponectin [Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
• Change in Soluble Intercellular Adhesion Marker [Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
• Changes in Renin-Angiontensin-Alsosterone System biomarkers profiling [Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
• Change in Systolic Blood pressure [Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
• Change in Diastolic Blood pressure [Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]

Secondary outcome measures (12)

• Change in Dietary habits [Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
• Change in exercise habits [Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
• Patient Health Questionnaire-9 (PHQ-9) [Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
• Generalized Anxiety Disorder-7 questionnaire (GAD-7) [Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
• Change in Anthropomorphic outcomes - Body Mass Index (BMI) [Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
• Change in Anthropomorphic outcomes - Waist circumference [Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
• Change in Anthropomorphic outcomes - Bioimpedence [Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
• Change in Anthropomorphic outcomes - Resting metabolic rate [Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
• Change in Anthropomorphic outcomes - Cardiorespiratory Fitness [Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
• Change in complete blood count (CBC) [Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
• Change in Liver panel profile [Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
• Change in Renal panel profile [Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]

Eligibility 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 1 center

• University of Kentucky — Lexington

Identifiers

NCT: NCT06967389 · 98420

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗