Clinical trial NCT06967389: Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity
Official title: Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity (MODERN)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
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
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from the University of Kentucky's High BMI and/or Pediatric Nephrology Clinics.

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

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.

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)

Primary outcomes:
measure: Change in medication use
timeFrame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
measure: Change in Lipid Profile
timeFrame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
measure: Change in C-reactive protein
timeFrame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
measure: Change in Tumor necrosis factor
timeFrame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
measure: Change in Interleukin-6
timeFrame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
measure: Change in Adiponectin
timeFrame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
measure: Change in Soluble Intercellular Adhesion Marker
timeFrame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
measure: Changes in Renin-Angiontensin-Alsosterone System biomarkers profiling
timeFrame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
measure: Change in Systolic Blood pressure
timeFrame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
measure: Change in Diastolic Blood pressure
timeFrame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
measure: Change in ambulatory blood pressure
timeFrame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
measure: Change in Cardiac structure
timeFrame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
measure: Change in Cardiac function (Ejection Fraction)
timeFrame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
measure: Change in Cardiac function (Stroke Volume (SV)
timeFrame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
measure: Change in Cardiac function (Cardiac Output (CO)
timeFrame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
measure: Change in Cardiac function (Wall motion)
timeFrame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
measure: Change in Cardiac function (Valve motion)
timeFrame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Secondary outcomes:
measure: Change in Dietary habits
timeFrame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
measure: Change in exercise habits
timeFrame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
measure: Generalized Anxiety Disorder-7 questionnaire (GAD-7)
timeFrame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
measure: Change in Anthropomorphic outcomes - Body Mass Index (BMI)
timeFrame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
measure: Change in Anthropomorphic outcomes - Waist circumference
timeFrame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
measure: Change in Anthropomorphic outcomes - Bioimpedence
timeFrame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
measure: Change in Anthropomorphic outcomes - Resting metabolic rate
timeFrame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
measure: Change in Anthropomorphic outcomes - Cardiorespiratory Fitness
timeFrame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
measure: Change in complete blood count (CBC)
timeFrame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
measure: Change in Liver panel profile
timeFrame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
measure: Change in Renal panel profile
timeFrame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
measure: Change in Thyroid panel profile
timeFrame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
measure: Change in Fasting glucose
timeFrame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
measure: Change in Fasting Insulin
timeFrame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
measure: Change in hyperglycemia assessed by Homeostatic Model Assessment of Insulin Resistance, (HOMA-IR)
timeFrame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: John Bauer, PhD
role: STUDY_CHAIR
affiliation: University of Kentucky
name: Margaret Murphy, RD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kentucky
name: Aurelia Radulescu, MD
role: STUDY_DIRECTOR
References: