Effect of GLP-1 Receptor Agonism on Weight and Caloric Intake in Subjects After Sleeve Gastrectomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Weight
研究概览
简要总结
Observational studies suggest that bariatric surgery is the most effective intervention for weight loss. Comparative effectiveness of Roux-en-Y Gastric Bypass (RYGB) and Sleeve Gastrectomy (SG) demonstrate that RYGB is significantly superior to SG in terms of weight loss and glycemic control. Both RYGB and SG increase GLP-1 concentrations which directly affect B-cell function. Data has shown that the postprandial rise in GLP-1 might affect feeding behavior after RYGB and to a lesser extent SG, where the increase in GLP-1 is less marked. In this study the investigators propose to randomize subjects undergoing SG to receive either placebo or Liraglutide, a GLP-1 receptor agonist, to compare weight loss and CV risk factors.
详细描述
A total of 75, non diabetic adults, scheduled for bariatric surgery at Mayo Clinic Rochester, will be enrolled. Of these, 25 will be scheduled for Roux-en-Y Gastric Bypass surgery (RYGB), while the remainder (50) will be scheduled for Sleeve Gastrectomy (SG). The study team will play no role in assignment of the surgical procedure. Following surgery, at month 3, subjects undergoing SG will be randomized to either Saxenda or placebo, subcutaneously once daily. Subjects randomized to Saxenda or placebo will take for the duration of the study (33 months). Follow up study visits for all subjects will be timed to coincide with the standard clinical follow up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double-blind design.
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 20-65 years of age
- •Seen at Mayo Clinic Nutrition Clinic and have received authorization for bariatric surgery.
- •No active physical illness which will interfere with mobility or weight loss after bariatric surgery.
- •Females who are sexually active and able to become pregnant must agree to use birth control for duration of study if randomized to Saxenda/Placebo.
排除标准
- •Prior use of glucose lowering medication in the 3 months prior to screening.
- •A fasting glucose ≥ 126mg/dl or an HbA1c ≥ 6.5% will be taken as evidence of type 2 diabetes and therefore patients will be deemed ineligible for participation.
- •Prior abdominal surgery other than cholecystectomy, appendectomy or hysterectomy.
- •Pregnancy or active consideration of pregnancy during the period of study. Subjects will be discontinued if they become pregnant during the study.
- •Hypersensitivity to liraglutide or any product components.
- •Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia type
- •Prior history of pancreatitis, cholelithiasis or cholecystitis.
- •Concurrent use of insulin or any other GLP-1 receptor agonist.
- •Active, severe psychiatric disease
研究组 & 干预措施
Sleeve Gastrectomy Placebo
Subjects undergoing Sleeve Gastrectomy (SG) will be randomized 1:1 at the time of 3 month visit after bariatric surgery.
干预措施: Placebos (Drug)
Sleeve Gastrectomy Saxenda
Subjects undergoing Sleeve Gastrectomy (SG) will be randomized 1:1 at the time of 3 month visit after bariatric surgery.
干预措施: Saxenda (Drug)
RYGB
Twenty five subjects will be recruited from the Nutrition Clinic at Mayo Clinic Rochester prior to undergoing RYGB surgery.
干预措施: RYGB (Procedure)
结局指标
主要结局
Weight
时间窗: baseline and 36 months
Subjects calculated weight in kilograms
次要结局
- Systolic Blood Pressure(baseline and 36 months)
- Diastolic Blood Pressure(baseline and 36 months)
- Low-density Lipoprotein (LDL)(baseline and 36 months)