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NCT Number: NCT06967389

Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity

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

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Key information

Conditions

Obesity and Overweight Body Weight Body Weight Changes Cardiovascular Disease Risk Factor Nutrition Disorders Nutritional and Metabolic Diseases Obese Adolescents Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss Weight Management

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Kentucky

Lexington, Kentucky, 40506, United States

Location status: Recruiting

Location contact

Aftab Chishti, MD

SUB_INVESTIGATOR

Amanda Wilburn, BA CCRP

CONTACT

[email protected]

8595620670

Aurelia Radulescu, MD

SUB_INVESTIGATOR

Douglas Schneider, MD

SUB_INVESTIGATOR

Hong Huang, PhD

SUB_INVESTIGATOR

Jody Clasey, PhD

SUB_INVESTIGATOR

John Bauer, PhD

PRINCIPAL_INVESTIGATOR

Margaret Murphy, RD PhD

SUB_INVESTIGATOR

Nermin Ahmed, RD PhD

CONTACT

[email protected]

Preeti Ramachandran, MD

SUB_INVESTIGATOR

Robin Shoemaker, PhD

SUB_INVESTIGATOR

Stefan Kiessling, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ozempic®

Drug

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

Primary outcomes

  1. 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

  2. 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

  3. Change in C-reactive protein

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

    data obtained from blood samples

  4. Change in Tumor necrosis factor

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

    data obtained from blood samples

  5. Change in Interleukin-6

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

    data obtained from blood samples

  6. Change in Adiponectin

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

    data obtained from blood samples

  7. Change in Soluble Intercellular Adhesion Marker

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

    data obtained from blood samples

  8. 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.

  9. Change in Systolic Blood pressure

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

  10. Change in Diastolic Blood pressure

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

    Blood pressure (systolic/diastolic) (mmHg) ambulatory blood pressure monitoring (ABPM) (mmHg) will be taken at the listed timepoints.

  11. Change in ambulatory blood pressure

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

  12. Change in Cardiac structure

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

    Changes from baseline cardiac MRI and/or cardiac echocardiograms (ECHO) will be assessed including overall heart and chamber size, wall thickness, etc.

  13. Change in Cardiac function (Ejection Fraction)

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

    Changes from baseline cardiac MRI and/or cardiac echocardiograms (ECHO) will be assessed.

  14. Change in Cardiac function (Stroke Volume (SV)

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

    Changes from baseline cardiac MRI and/or cardiac echocardiograms (ECHO) will be assessed.

  15. Change in Cardiac function (Cardiac Output (CO)

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

    Changes from baseline cardiac MRI and/or cardiac echocardiograms (ECHO) will be assessed.

  16. Change in Cardiac function (Wall motion)

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

    Changes from baseline cardiac MRI and/or cardiac echocardiograms (ECHO) will be assessed.

  17. Change in Cardiac function (Valve motion)

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

    Changes from baseline cardiac MRI and/or cardiac echocardiograms (ECHO) will be assessed.

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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

  5. Change in Anthropomorphic outcomes - Body Mass Index (BMI)

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

  6. Change in Anthropomorphic outcomes - Waist circumference

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

  7. 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

  8. 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).

  9. 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

  10. 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

  11. Change in Liver panel profile

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

    -plasma/serum samples will be analyzed. The individual components are grouped as a panel to for an overall evaluation of the system's functioning

  12. Change in Renal panel profile

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

    -plasma/serum samples will be analyzed. The individual components are grouped as a panel to for an overall evaluation of the system's functioning

  13. Change in Thyroid panel profile

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

    -plasma/serum samples will be analyzed. The individual components are grouped as a panel to for an overall evaluation of the system's functioning

  14. Change in Fasting glucose

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

    -plasma/serum samples will be analyzed

  15. Change in Fasting Insulin

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

    -plasma/serum samples will be analyzed

  16. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Heather Collins, BSN RN CCRP

CONTACT

[email protected]

859-562-1103

Margaret Murphy, RD PhD

CONTACT

[email protected]

859-323-2969

Sponsors and collaborators

Lead sponsor

John Bauer

Other

Registry information

Official study title

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

Acronym: MODERN

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
May 13, 2025
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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