Randomized Control Trial of Sleeve Gastrectomy With Tirzepatide in Maximizing Weight Loss
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Weight Loss
研究概览
简要总结
This study examines whether adding tirzepatide-a medication that helps with weight loss-after sleeve gastrectomy surgery can help people lose more weight after the surgery; better improve conditions like Type 2 diabetes, high blood pressure, high cholesterol, and sleep apnea after surgery and; whether this causes more complications or side effects compared to surgery alone.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult 18 to 65 years of age
- •Body Mass Index >35 with comorbidity of Type 2 Diabetes and/or Hypertension and/or Hyperlipidemia and/or Obstructive Sleep Apnea OR Body Mass Index >40 with or without comorbidity
- •Undergoing primary sleeve gastrectomy
排除标准
- •Prior metabolic and bariatric surgery
- •Prior use of GLP-1 agonist
- •Prior history of pancreatitis
- •Personal/family history of medullary thyroid cancer or MEN type 2
- •Secondary cause of obesity
- •Any eating disorder
- •Pregnancy/lactation
- •History of acute coronary syndrome or myocardial infarction
- •History of stroke
- •Hepatic dysfunction: AST/ALT >3 ULN
- •Renal dysfunction eGFR<45ml/min/1.73m2
- •Active malignancy
- •History of diabetic retinopathy
- •History of gastroparesis
研究组 & 干预措施
SG-T: sleeve gastrectomy with tirzepatide
In this study, the intervention group (n=21) are patients who will undergo sleeve gastrectomy and receive tirzepatide. Patients who were selected in this arm will undergo a 4-week dose escalation period. Starting at 6 months after surgery they will receive weekly 2.5mg doses (for 4 weeks). Afterwards, they will receive weekly 5mg doses. They will maintain this dose until 12 months after surgery.
干预措施: Mounjaro (Drug)
SG-T: sleeve gastrectomy with tirzepatide
In this study, the intervention group (n=21) are patients who will undergo sleeve gastrectomy and receive tirzepatide. Patients who were selected in this arm will undergo a 4-week dose escalation period. Starting at 6 months after surgery they will receive weekly 2.5mg doses (for 4 weeks). Afterwards, they will receive weekly 5mg doses. They will maintain this dose until 12 months after surgery.
干预措施: Sleeve Gastrectomy (Procedure)
SG-A: sleeve gastrectomy alone
In this study the control group (n=21) are patients who will undergo sleeve gastrectomy alone.
干预措施: Sleeve Gastrectomy (Procedure)
结局指标
主要结局
Weight Loss
时间窗: 12 months after surgery
次要结局
- Weight Loss(18 months after surgery)
- Type 2 Diabetes(18 months after surgery)
- High Blood Pressure(18 months after surgery)
- High Cholesterol(18 months after surgery)
- Sleep Apnea(18 months after surgery)
- Complications/Side Effects(18 months after surgery)
研究者
Nicholas Skertich
Assistant Professor
Rush University Medical Center