Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity (MODERN)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- John Bauer
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Soluble Intercellular Adhesion Marker
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Treatment Group
All participants in this study will be given the study drug.
干预措施: Ozempic® (Drug)
结局指标
主要结局
Change in Soluble Intercellular Adhesion Marker
时间窗: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
data obtained from blood samples
Change in medication use
时间窗: 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
时间窗: 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
时间窗: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
data obtained from blood samples
Change in Tumor necrosis factor
时间窗: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
data obtained from blood samples
Change in Interleukin-6
时间窗: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
data obtained from blood samples
Change in Adiponectin
时间窗: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
data obtained from blood samples
Changes in Renin-Angiontensin-Alsosterone System biomarkers profiling
时间窗: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Changes in RAAS biomarkers at the defined study points will be evaluated.
Change in Systolic Blood pressure
时间窗: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in Diastolic Blood pressure
时间窗: 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.
Change in ambulatory blood pressure
时间窗: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in Cardiac structure
时间窗: 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.
Change in Cardiac function (Ejection Fraction)
时间窗: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Changes from baseline cardiac MRI and/or cardiac echocardiograms (ECHO) will be assessed.
Change in Cardiac function (Stroke Volume (SV)
时间窗: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Changes from baseline cardiac MRI and/or cardiac echocardiograms (ECHO) will be assessed.
Change in Cardiac function (Cardiac Output (CO)
时间窗: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Changes from baseline cardiac MRI and/or cardiac echocardiograms (ECHO) will be assessed.
Change in Cardiac function (Wall motion)
时间窗: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Changes from baseline cardiac MRI and/or cardiac echocardiograms (ECHO) will be assessed.
Change in Cardiac function (Valve motion)
时间窗: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Changes from baseline cardiac MRI and/or cardiac echocardiograms (ECHO) will be assessed.
次要结局
- Change in complete blood count (CBC)(Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment)
- Change in Dietary habits(Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment)
- Change in exercise habits(Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment)
- Patient Health Questionnaire-9 (PHQ-9)(Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment)
- Generalized Anxiety Disorder-7 questionnaire (GAD-7)(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(Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment)
- Change in Anthropomorphic outcomes - Resting metabolic rate(Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment)
- Change in Anthropomorphic outcomes - Cardiorespiratory Fitness(Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment)
- Change in Liver panel profile(Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment)
- Change in Renal panel profile(Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment)
- Change in Thyroid panel profile(Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment)
- Change in Fasting glucose(Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment)
- Change in Fasting Insulin(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)