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Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will be in the study for 12 months (+/- 2 months) depending on when they reach the maintenance dose of semaglutide."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether semaglutide, a weight-loss drug, changes signs of heart disease and other health risks in children ages 12–15 with severe obesity (class 2 or 3). All participants will take semaglutide and have tests of their heart, body fat and muscle, and fitness over about 12 months.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are ages 12–15.
  • Receive care at the University of Kentucky Pediatric High BMI Clinic.
  • Have severe obesity, called class 2 or 3.
  • Meet the medical requirements to take semaglutide for weight loss.

Who can't join

  • Currently take prescription medicines for weight loss or high blood pressure.
  • Have an urgent concern involving an organ, such as kidney or liver disease or a condition present from birth.
  • Have an active infection when joining the study.
  • Have used steroids that affect the whole body for more than 3 months or within the month before joining. Inhaled steroids, eye drops, nose sprays, and skin treatments do not count.
  • Cannot do exercise testing or cannot have an MRI scan.
  • Have a condition present from birth or a genetic condition known to be linked to obesity.
  • Are pregnant.
  • Have a personal or family history of medullary thyroid cancer, or have multiple endocrine neoplasia type 2, a condition that can cause tumors in hormone-making glands.

Simplified for readability. The official criteria below are what the study team uses.

Official 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)

Study sites (1)

KY