Early Reinitiation of Semaglutide Post-Sleeve Gastrectomy in Youth: A Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Percent Body Mass Index
研究概览
简要总结
This is a Phase 3a, randomized, parallel-controlled trial designed to compare the early re-initiation of semaglutide, starting two weeks after sleeve gastrectomy, to standard care (no pharmacotherapy following surgery). The trial will involve 150 youth with severe obesity who have been on semaglutide 2.4 mg weekly for at least 3 months prior to surgery. Participants will be randomized to either (1) semaglutide 2.4 mg weekly or (2) standard care for 24 months. Primary, secondary, and tertiary outcomes will be assessed at multiple time points: 1-month, day of surgery, and 1-, 3-, 6-, 9-, 12-, 18-, and 24-months postoperatively. We hypothesize that early re-initiation of semaglutide will be safe, well-tolerated, and lead to greater improvements in obesity, cardiometabolic risk, and eating behaviors.
详细描述
Study Design: Phase 3a Randomized Controlled Trial of Early Re-initiation of Semaglutide After Sleeve Gastrectomy in Youth with Severe Obesity
Study Type: Interventional (Clinical Trial)
Study Phase: Phase 3a
Allocation: Randomized
Intervention Model: Parallel Assignment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ages 12 to 18 years
- •Tanner stage 3 or higher
- •severe obesity (defined as a BMI greater than 35 kg/m2 or BMI ≥140% of the 95th percentile)
- •currently undergoing primary surgical weight loss through the pediatric bariatric surgery pathway at Children's Hospital Los Angeles
- •be willing to have blood collected before and after surgical procedure at defined points
- •be willing to have clinical data entered into a prospective database; 8) presence of a consenting caregiver
- •be taking semaglutide 2.4 mg weekly as part of their routine medical care prior to surgery as part of their obesity treatment program, apart from any planned surgical procedure.
排除标准
- •have a previous diagnosis of type 1 diabetes
- •taking any medications known to influence body composition or prevent weight loss or promote weight gain (e.g. prednisone)
- •have been diagnosed with syndromes or diseases that may influence the postoperative course (e.g., Cushing syndrome, Down syndrome, Prader Willi Syndrome)
- •have significant comorbid medical conditions necessitating frequent hospitalization that may require interruption of medications and/or that would make early re-initiation of semaglutide unsafe due to the other medical comorbidities
- •refuse to comply with eligibility criteria.
研究组 & 干预措施
Standard Care
Standard of care following bariatric surgery. No Reinitiation of obesity optimizing medications.
Early reinitiation
Early Reinitiation of semaglutide at 2 weeks after bariatric surgery per standard titration starting at 0.25 mg weekly and titrating to 2.4 mg weekly
干预措施: Semaglutide 2.4 mg (Drug)
结局指标
主要结局
Percent Body Mass Index
时间窗: From enrollment to the end of the end of the study at 24 months
Percent Body Mass Index (%BMI) is calculated as the participant's BMI at each assessment time point expressed as a percentage of the 95th percentile BMI for age and sex, based on CDC growth charts. This metric is commonly used in pediatric populations to more accurately reflect degrees of obesity in youth, particularly at the upper end of the BMI distribution where standard BMI z-scores may lose sensitivity. Calculation Formula: %BMI = (Participant's BMI / 95th percentile BMI for age and sex) × 100 Type (continuous) Units (Percent) Justification: %BMI is used as a more precise and interpretable measure of adiposity in children and adolescents with severe obesity. It allows for consistent tracking of obesity severity and treatment response over time, even in populations whose BMI values significantly exceed the 95th percentile.
次要结局
- Modified percent time in range(From enrollment to the end of the study period at 24 months)
研究者
Alaina P. Vidmar, MD
Associate Professor of Pediatrics, Director of Obesity Medicine and Bariatric Surgery
Children's Hospital Los Angeles