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Идёт набор NCT06967389

Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity

— Наблюдательное Obesity and Overweight Obese Adolescents Weight Management Weight Loss

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Ozempic®.
Кому может быть актуально
Состояния в реестре: Obesity and Overweight, Obese Adolescents, Weight Management, Weight Loss. Базовые параметры: 12 лет — 17 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

  • Препарат Ozempic®
    The study medication will be given in accordance with standard of care dosing schedule.

Первичные конечные точки

  • Change in medication use [Срок оценки: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
  • Change in Lipid Profile [Срок оценки: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
  • Change in C-reactive protein [Срок оценки: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
  • Change in Tumor necrosis factor [Срок оценки: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
  • Change in Interleukin-6 [Срок оценки: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
  • Change in Adiponectin [Срок оценки: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
  • Change in Soluble Intercellular Adhesion Marker [Срок оценки: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
  • Changes in Renin-Angiontensin-Alsosterone System biomarkers profiling [Срок оценки: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
  • Change in Systolic Blood pressure [Срок оценки: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
  • Change in Diastolic Blood pressure [Срок оценки: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
Вторичные конечные точки (12)
  • Change in Dietary habits [Срок оценки: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
  • Change in exercise habits [Срок оценки: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
  • Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
  • Generalized Anxiety Disorder-7 questionnaire (GAD-7) [Срок оценки: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
  • Change in Anthropomorphic outcomes - Body Mass Index (BMI) [Срок оценки: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
  • Change in Anthropomorphic outcomes - Waist circumference [Срок оценки: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
  • Change in Anthropomorphic outcomes - Bioimpedence [Срок оценки: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
  • Change in Anthropomorphic outcomes - Resting metabolic rate [Срок оценки: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
  • Change in Anthropomorphic outcomes - Cardiorespiratory Fitness [Срок оценки: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
  • Change in complete blood count (CBC) [Срок оценки: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
  • Change in Liver panel profile [Срок оценки: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
  • Change in Renal panel profile [Срок оценки: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • University of Kentucky — Lexington

Идентификаторы

NCT: NCT06967389 · 98420

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗