RECRUITING

Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-06-12
Study Completion:2027-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06967389

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Patient seen at University of Kentucky Pediatric High BMI Clinic
  2. * Diagnosis of Obesity Class 2 or 3
  3. * Meeting the clinical criteria for the medical intervention with semaglutide for weight loss
  1. * Any current prescribed anti-obesity medications (AOM) such as Orlistat, Phentermine, Qsymia (Phentermine/Topiramate), Liraglutide, Semaglutide, and Setmelanotide
  2. * Any current prescribed anti-hypertensive medications
  3. * Any specific end-organ acute concerns (kidney disease, liver disease, congenital disease).
  4. * Any active infections at enrollment.
  5. * Any systemic steroid use longer than 3 month use or within the last month before enrollment (not including inhaled, ophthalmic, intranasal, and topical).
  6. * Any limitations that would make exercise testing not possible.
  7. * Any congenital abnormality or genetic syndrome known to be associated with obesity
  8. * Pregnancy
  9. * Inability to receive an MRI
  10. * Personal or family history of medullary thyroid carcinoma (per product insert)
  11. * Patients with Multiple Endocrine Neoplasia syndrome type 2 (per product insert)

Contacts and Locations

Study Contact

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

Principal Investigator

John Bauer, PhD
STUDY_CHAIR
University of Kentucky
Margaret Murphy, RD PhD
PRINCIPAL_INVESTIGATOR
University of Kentucky
Aurelia Radulescu, MD
STUDY_DIRECTOR
University of Kentucky

Study Locations (Sites)

University of Kentucky
Lexington, Kentucky, 40506
United States

Collaborators and Investigators

Sponsor: John Bauer

  • John Bauer, PhD, STUDY_CHAIR, University of Kentucky
  • Margaret Murphy, RD PhD, PRINCIPAL_INVESTIGATOR, University of Kentucky
  • Aurelia Radulescu, MD, STUDY_DIRECTOR, University of Kentucky

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-12
Study Completion Date2027-07

Study Record Updates

Study Start Date2025-06-12
Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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