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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:
Participants will be given semaglutide for this study. During the course of the study, participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | All participants in this study will be given the study drug. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ozempic® | Drug | The study medication will be given in accordance with standard of care dosing schedule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in medication use | This will be assessed by reviewing changes in the electronic medical record | Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment |
| Change in Lipid Profile | 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 | Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment |
| Change in C-reactive protein | data obtained from blood samples | Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment |
| Change in Tumor necrosis factor | data obtained from blood samples | Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment |
| Change in Interleukin-6 | data obtained from blood samples | Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment |
| Change in Adiponectin | data obtained from blood samples | Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment |
| Change in Soluble Intercellular Adhesion Marker | data obtained from blood samples | Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Dietary habits | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Participants will be recruited from the University of Kentucky's High BMI and/or Pediatric Nephrology Clinics.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| John Bauer, PhD | University of Kentucky | Study Chair |
| Margaret Murphy, RD PhD | University of Kentucky | Principal Investigator |
| Aurelia Radulescu, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Recruiting | Lexington | Kentucky | 40506 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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Blood and urine samples will be stored.
| Changes in Renin-Angiontensin-Alsosterone System biomarkers profiling | Changes in RAAS biomarkers at the defined study points will be evaluated. | Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment |
| Change in Systolic Blood pressure | Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment |
| Change in Diastolic Blood pressure | Blood pressure (systolic/diastolic) (mmHg) ambulatory blood pressure monitoring (ABPM) (mmHg) will be taken at the listed timepoints. | Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment |
| Change in ambulatory blood pressure | Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment |
| Change in Cardiac structure | Changes from baseline cardiac MRI and/or cardiac echocardiograms (ECHO) will be assessed including overall heart and chamber size, wall thickness, etc. | Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment |
| Change in Cardiac function (Ejection Fraction) | Changes from baseline cardiac MRI and/or cardiac echocardiograms (ECHO) will be assessed. | Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment |
| Change in Cardiac function (Stroke Volume (SV) | Changes from baseline cardiac MRI and/or cardiac echocardiograms (ECHO) will be assessed. | Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment |
| Change in Cardiac function (Cardiac Output (CO) | Changes from baseline cardiac MRI and/or cardiac echocardiograms (ECHO) will be assessed. | Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment |
| Change in Cardiac function (Wall motion) | Changes from baseline cardiac MRI and/or cardiac echocardiograms (ECHO) will be assessed. | Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment |
| Change in Cardiac function (Valve motion) | Changes from baseline cardiac MRI and/or cardiac echocardiograms (ECHO) will be assessed. | Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment |
| Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment |
| Change in exercise habits | 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 | Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment |
| Patient Health Questionnaire-9 (PHQ-9) | 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. | Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment |
| Generalized Anxiety Disorder-7 questionnaire (GAD-7) | 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 | Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment |
| Change in Anthropomorphic outcomes - Body Mass Index (BMI) | Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment |
| Change in Anthropomorphic outcomes - Waist circumference | Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment |
| Change in Anthropomorphic outcomes - Bioimpedence | Whole-body electrical resistance will be measured with the subjects using the BodyStat Quadscan 4000 Bioelectric Impedance Analyzer | Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment |
| Change in Anthropomorphic outcomes - Resting metabolic rate | A handheld resting metabolic rate (RMR) calculator/indirect calorimeter (MedGem RMR) will be used to estimate the RMR (caloric needs). | Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment |
| Change in Anthropomorphic outcomes - Cardiorespiratory Fitness | Maximal Graded Exercise Testing (Maximal GXT): The maximal graded exercise tests will be performed using an indirect calorimetry testing system | Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment |
| Change in complete blood count (CBC) | plasma/serum samples will be analyzed | Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment |
| Change in Liver panel profile | -plasma/serum samples will be analyzed. The individual components are grouped as a panel to for an overall evaluation of the system's functioning | Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment |
| Change in Renal panel profile | -plasma/serum samples will be analyzed. The individual components are grouped as a panel to for an overall evaluation of the system's functioning | Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment |
| Change in Thyroid panel profile | -plasma/serum samples will be analyzed. The individual components are grouped as a panel to for an overall evaluation of the system's functioning | Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment |
| Change in Fasting glucose | -plasma/serum samples will be analyzed | Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment |
| Change in Fasting Insulin | -plasma/serum samples will be analyzed | Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment |
| Change in hyperglycemia assessed by Homeostatic Model Assessment of Insulin Resistance, (HOMA-IR) | Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment |
| University of Kentucky |
| Study Director |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |