Stanford Pediatric Healthy Weight Index
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Percent Reduction in BMI
研究概览
简要总结
This study will develop a simple index to measure how well the body uses insulin and overall heart and metabolic health in children and teens with obesity. The investigators will use data from wearable devices (like fitness trackers) and glucose monitors, along with lab tests, to learn how activity and glucose relate to metabolic problems.
详细描述
This is a prospective cohort study to develop a metabolic index for insulin sensitivity and cardiometabolic fitness among children and adolescents with obesity. Adolescent patients undergoing evaluation for bariatric surgery or medical management of wight using GLP-1 agonist therapies will be consented for participation. Participants will be given a wearable fitness device and a continuous glucose monitor. Continuous monitoring will be carried out at three time points: preoperative or prior to starting medication, perioperative or after 3-4 weeks of GLP1 use during early treatment phase, and 3 months post-operatively or 3 months after dose stabilization or discontinuation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Class 2 and 3 obesity
- •Patient in the Adolescent Bariatric Program at Stanford Children's that is eligible for either laparoscopic sleeve gastrectomy or GLP1 Receptor Agonist Therapy
- •Willingness to wear a CGM and physiological monitor for the duration of the study.
排除标准
- •Hypothalamic and syndromic obesity
- •BMI > 55
- •Plan to undergo bariatric surgical procedure other than sleeve gastrectomy
- •Prior bariatric surgical procedure
- •Active GLP treatment (within past 3 months)
- •Unable to read, understand, or complete the informed consent in English or Spanish
结局指标
主要结局
Percent Reduction in BMI
时间窗: baseline through study completion, an average of 4 months
assessment of change in BMI from pre-intervention to post-intervention
HbA1c
时间窗: baseline through study completion, an average of 4 months
change in HbA1c levels from pre-intervention to post-intervention
Body Weight
时间窗: baseline through study completion, an average of 4 months
Change in body weight (kg)
Lipid Panel
时间窗: baseline through study completion, an average of 4 months
changes in lipid panel levels from pre-intervention to post-intervention
Fasting Glucose
时间窗: baseline through study completion, an average of 4 months
change in fasting glucose levels from pre-intervention to post-intervention
Fasting Insulin
时间窗: baseline through study completion, an average of 4 months
change in fasting insulin levels from pre-intervention to post-intervention
Liver Enzymes
时间窗: baseline through study completion, an average of 4 months
changes in liver enzymes from pre-intervention to post-intervention
次要结局
- Obesity-related Comorbidities(baseline through study completion, an average of 4 months)
研究者
Karl Sylvester
Professor of Surgery
Stanford University