Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity

NCT06967389 | Recruiting FDA Drug

• 1 other identifier: 98420
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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 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

Conditions

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

Keywords

semaglutide; Wegovy; Ozempic; obesity; overweight; adolescent; weight management; weight loss

Outcome Measures

Primary Outcomes (17)

• Change in medication use

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

  Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

• Change in Lipid Profile

  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

  Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

• Change in C-reactive protein

  data obtained from blood samples

  Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

• Change in Tumor necrosis factor

  data obtained from blood samples

  Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

• Change in Interleukin-6

  data obtained from blood samples

  Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

• Change in Adiponectin

  data obtained from blood samples

  Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

• Change in Soluble Intercellular Adhesion Marker

  data obtained from blood samples

  Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

• Changes in Renin-Angiontensin-Alsosterone System biomarkers profiling

  Changes in RAAS biomarkers at the defined study points will be evaluated.

  Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

• Change in Systolic Blood pressure

  Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

• Change in Diastolic Blood pressure

  Blood pressure (systolic/diastolic) (mmHg) ambulatory blood pressure monitoring (ABPM) (mmHg) will be taken at the listed timepoints.

  Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

• Change in ambulatory blood pressure

  Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

• Change in Cardiac structure

  Changes from baseline cardiac MRI and/or cardiac echocardiograms (ECHO) will be assessed including overall heart and chamber size, wall thickness, etc.

  Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

• Change in Cardiac function (Ejection Fraction)

  Changes from baseline cardiac MRI and/or cardiac echocardiograms (ECHO) will be assessed.

  Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

• Change in Cardiac function (Stroke Volume (SV)

  Changes from baseline cardiac MRI and/or cardiac echocardiograms (ECHO) will be assessed.

  Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

• Change in Cardiac function (Cardiac Output (CO)

  Changes from baseline cardiac MRI and/or cardiac echocardiograms (ECHO) will be assessed.

  Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

• Change in Cardiac function (Wall motion)

  Changes from baseline cardiac MRI and/or cardiac echocardiograms (ECHO) will be assessed.

  Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

• Change in Cardiac function (Valve motion)

  Changes from baseline cardiac MRI and/or cardiac echocardiograms (ECHO) will be assessed.

  Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

Secondary Outcomes (16)

• Change in Dietary habits

  Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

• Change in exercise habits

  Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

• Patient Health Questionnaire-9 (PHQ-9)

  Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

• Generalized Anxiety Disorder-7 questionnaire (GAD-7)

  Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

• Change in Anthropomorphic outcomes - Body Mass Index (BMI)

  Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

Study Arms (1)

Treatment Group

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

Drug: Ozempic®

Interventions

Ozempic® DRUG

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

Treatment Group

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from the University of Kentucky's High BMI and/or Pediatric Nephrology Clinics.

You may qualify if:

• 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 may not qualify if:

• 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)

Sponsors & Collaborators

• John Bauer: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and urine samples will be stored.

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• John Bauer, PhD

  University of Kentucky

  STUDY CHAIR

• Margaret Murphy, RD PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

• Aurelia Radulescu, MD

  University of Kentucky

  STUDY DIRECTOR

Central Study Contacts

Margaret Murphy, RD PhD

CONTACT

859-323-2969; maggie.murphy@uky.edu

Heather Collins, BSN RN CCRP

CONTACT

859-562-1103; heather.collins1@uky.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: May 13, 2025
• Study Start: June 12, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)