Medications After Adolescent Bariatric Surgery Protocol for Inadequate Weight Loss Following Sleeve Gastrectomy in Adolescents and Young Adults: A Pilot Feasibility Study
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Number of participants who are able to consent for off-label medication use as a measure of feasibility
研究概览
简要总结
This study will assess the feasibility to assess practicality of early weight loss medication usage in adolescent patients post-VSG with inadequate weight loss. Participants who enroll in the study will be prescribed off-label use of weight loss medications for a period of up to 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Surgical patients in the LPCH/Stanford bariatric and weight management clinics
- •Inadequate weight loss after vertical sleeve gastrectomy
排除标准
- •Adequate weight loss after surgery;
- •Unwilling to consent or adhere to safety monitoring plan;
- •Any life-threatening or terminal diseases
- •Currently pregnant, breastfeeding, or thinking of becoming pregnant
- •Allergy or medical contraindication to phentermine or topiramate;
- •History of drug or alcohol abuse;
- •No known medication interactions;
- •Significant renal or hepatic impairment;
- •Participation in a study of an investigational medication 30 days prior to screening, while the patient is on study, and for 30 days after their last dose of study treatment
研究组 & 干预措施
Medication Group
Adolescent patients post vertical sleeve gastrectomy who have had inadequate weight loss, who consented for use of off-label medications prescribed at the discretion (one or both) of physician.
Patients will be followed every 2-12 weeks over one year.
All patients in this group will continue to follow the standard of care procedures of our multidisciplinary bariatric clinic, including frequent follow-up appointments, nutrition guidance, vitamin supplementation, exercise instruction, and healthy lifestyle education.
干预措施: Topiramate (Drug)
Medication Group
Adolescent patients post vertical sleeve gastrectomy who have had inadequate weight loss, who consented for use of off-label medications prescribed at the discretion (one or both) of physician.
Patients will be followed every 2-12 weeks over one year.
All patients in this group will continue to follow the standard of care procedures of our multidisciplinary bariatric clinic, including frequent follow-up appointments, nutrition guidance, vitamin supplementation, exercise instruction, and healthy lifestyle education.
干预措施: Phentermine (Drug)
结局指标
主要结局
Number of participants who are able to consent for off-label medication use as a measure of feasibility
时间窗: Up to 1 year
次要结局
- Average daily rate of compliance with medication administration(Up to 1 year)
- Percent change from baseline in % BMI(Baseline (initiation of medication), 1 year)
- Timing of the implementation of off-label medications after vertical sleeve gastrectomy(Up to 1 year)
- Type of weight loss medication prescribed(Up to 1 year)
- Number of participants experiencing side effects(Up to 1 year)
研究者
Janey Pratt
Clinical Associate Professor of Surgery
Stanford University