Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
John Bauer
Study ID
NCT06967389
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
12 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Jun 12, 2025
Status verified
Jul 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Treatment Group
    All participants in this study will be given the study drug.

Primary Outcome Measure

Change in medication use [ Time Frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of KentuckyLexingtonKentucky40506
Amanda Wilburn, BA CCRP
[email protected]
8595620670
Nermin Ahmed, RD PhD
[email protected]
John Bauer, PhD (PRINCIPAL_INVESTIGATOR)
Jody Clasey, PhD (SUB_INVESTIGATOR)
Hong Huang, PhD (SUB_INVESTIGATOR)
Margaret Murphy, RD PhD (SUB_INVESTIGATOR)
Aurelia Radulescu, MD (SUB_INVESTIGATOR)
Preeti Ramachandran, MD (SUB_INVESTIGATOR)
Douglas Schneider, MD (SUB_INVESTIGATOR)
Robin Shoemaker, PhD (SUB_INVESTIGATOR)
Aftab Chishti, MD (SUB_INVESTIGATOR)
Stefan Kiessling, MD (SUB_INVESTIGATOR)

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By research site
University of Kentucky· Lexington, KY

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