DRUG
Ozempic®
The study medication will be given in accordance with standard of care dosing schedule.
Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity
Status
Recruiting
Phase
Not applicable
Enrollment
50
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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
Full 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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
May 13, 2025
Study start
Jun 12, 2025
Primary completion
Jul 2027
Study completion
Jul 2028
Results posted
Not reported
Registry updated
Jul 21, 2026
Outcomes
What the study measures.
Primary outcomes
Change in medication use
Time frame · Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
This will be assessed by reviewing changes in the electronic medical record
Change in Lipid Profile
Time frame · Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
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
Change in C-reactive protein
Time frame · Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
data obtained from blood samples
Change in Tumor necrosis factor
Time frame · Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
data obtained from blood samples
Change in Interleukin-6
Time frame · Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
data obtained from blood samples
Change in Adiponectin
Time frame · Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
data obtained from blood samples
Change in Soluble Intercellular Adhesion Marker
Time frame · Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
data obtained from blood samples
Changes in Renin-Angiontensin-Alsosterone System biomarkers profiling
Time frame · Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Changes in RAAS biomarkers at the defined study points will be evaluated.
Secondary outcomes
Change in Dietary habits
Time frame · Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
It assesses the frequency and quality of dietary habits, such as the consumption of fruits, vegetables, whole grains, and unhealthy foods like sugary snacks and fast food. The scoring is typically based on a scale representing frequency: 0 = Never or less than once per week, 1 = 1-2 times per week, 2 = 3-4 times per week, 3 = 5-6 times per week, 4 = Daily or more. Higher scores on the healthy scale = better dietary habits
Change in exercise habits
Time frame · Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Assessed with the BMI Clinic dietary and exercise habit survey in which participants record the frequency of activities. It assesses the frequency, duration, and/or intensity of physical activity (e.g., walking, moderate activity, vigorous activity, including aerobic and strength training). For interpretation: High Score: Indicates sufficient physical activity Low Score: Suggests insufficient physical activity
Patient Health Questionnaire-9 (PHQ-9)
Time frame · Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
The PHQ-9 is a 9-item self-report questionnaire that is widely used to assess depression symptom severity. A PHQ-9 score ≥10 has a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively. Higher scores indicating greater depression severity.
Generalized Anxiety Disorder-7 questionnaire (GAD-7)
Time frame · Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
A 7 item self-complete questionnaire with very good sensitivity (89%) and specificity (82%) for Generalised Anxiety Disorder (GAD). Response scores for each item ranging from 0 (not at all) to 3 (every day). The range for the total score is 0 to 21, with higher scores representing greater symptoms of anxiety
Change in Anthropomorphic outcomes - Body Mass Index (BMI)
Time frame · Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in Anthropomorphic outcomes - Waist circumference
Time frame · Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in Anthropomorphic outcomes - Bioimpedence
Time frame · Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Whole-body electrical resistance will be measured with the subjects using the BodyStat Quadscan 4000 Bioelectric Impedance Analyzer
Change in Anthropomorphic outcomes - Resting metabolic rate
Time frame · Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
A handheld resting metabolic rate (RMR) calculator/indirect calorimeter (MedGem RMR) will be used to estimate the RMR (caloric needs).
Change in Anthropomorphic outcomes - Cardiorespiratory Fitness
Time frame · Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Maximal Graded Exercise Testing (Maximal GXT): The maximal graded exercise tests will be performed using an indirect calorimetry testing system
Change in complete blood count (CBC)
Time frame · Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
plasma/serum samples will be analyzed
Eligibility
Who can take part.
- Minimum age
- 12 Years
- Maximum age
- 17 Years
- Sex
- ALL
- Healthy volunteers
- No
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 locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
University of Kentucky
Lexington, Kentucky, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.