Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity

John Bauer50 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Obesity and Overweight Obese Adolescents

Interventions

Ozempic®DRUG

The study medication will be given in accordance with standard of care dosing schedule.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 17 Years

Medical Language ↔ Plain English

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)

Locations (1)

University of Kentucky

Lexington, Kentucky, United States

RECRUITING

Outcomes

Primary Outcomes

Change in medication use

This will be assessed by reviewing changes in the electronic medical record

Time frame: 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

Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

Change in C-reactive protein

data obtained from blood samples

Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

Change in Tumor necrosis factor

data obtained from blood samples

Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

Change in Interleukin-6

data obtained from blood samples

Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

Change in Adiponectin

data obtained from blood samples

Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

Change in Soluble Intercellular Adhesion Marker

data obtained from blood samples

Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

Changes in Renin-Angiontensin-Alsosterone System biomarkers profiling

Changes in RAAS biomarkers at the defined study points will be evaluated.

Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

Change in Systolic Blood pressure

Time frame: 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.

Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

Change in ambulatory blood pressure

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

Secondary Outcomes

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

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

Change in Anthropomorphic outcomes - Body Mass Index (BMI)

Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

Central Contacts

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Change in Anthropomorphic outcomes - Waist circumference

Time frame: 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

Time frame: 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).

Time frame: 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

Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

Change in complete blood count (CBC)

plasma/serum samples will be analyzed

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

Change in Fasting glucose

-plasma/serum samples will be analyzed

Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

Change in Fasting Insulin

-plasma/serum samples will be analyzed

Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

Change in hyperglycemia assessed by Homeostatic Model Assessment of Insulin Resistance, (HOMA-IR)

Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment