Effect of Ghrelin on Glucose Metabolism After Bariatric Surgery
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in plasma glucose levels with ghrelin versus saline.
研究概览
简要总结
The purpose of this study is to determine if the altered nutrient exposure to the GI tract after bariatric surgery reveals a negative incretin effect of ghrelin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI ≥ 35 kg/m2
- •Age 21-65 years
- •Weight ≤ 200 kg
排除标准
- •Type 2 or Type 1 diabetes
- •Medications that alter insulin sensitivity or carbohydrate metabolism
- •Positive pregnancy test
- •Known history of intestinal diseases including, but not limited to, inflammatory bowel disease (e.g. Chronic Ulcerative Colitis, Crohn's disease, celiac sprue)
- •Prior gastric or intestinal surgery or pancreas resection
- •History of cardiovascular disease, including but not limited to: myocardial infarction, angioplasty, arrhythmia, uncontrolled hypertension
- •History of chronic kidney disease or renal insufficiency; creatinine > 1.8 mg/dl.
- •History of chronic liver disease, including but not limited to: cirrhosis, hepatitis, portal hypertension; AST and/or ALT > 2x the upper limit of normal.
- •Abnormal ECG
研究组 & 干预措施
Vertical Sleeve Gastrectomy (VSG) NJ/PO
Patients that are undergoing routine VSG will be studied preoperatively, and at 1 month postoperatively. Each time point will have two study visits with a cross-over design. The first visit at each time point will be randomized to a human ghrelin or a saline infusion, with the alternate infusion at the second visit. At each study visit, an Oral Glucose Tolerance Test (OGTT) will be performed by administering glucose through a nasojejunal (NJ) feeding tube preoperatively and orally (PO) postoperatively.
干预措施: Oral Glucose Tolerance Test (OGTT) (Procedure)
Vertical Sleeve Gastrectomy (VSG) NJ/PO
Patients that are undergoing routine VSG will be studied preoperatively, and at 1 month postoperatively. Each time point will have two study visits with a cross-over design. The first visit at each time point will be randomized to a human ghrelin or a saline infusion, with the alternate infusion at the second visit. At each study visit, an Oral Glucose Tolerance Test (OGTT) will be performed by administering glucose through a nasojejunal (NJ) feeding tube preoperatively and orally (PO) postoperatively.
干预措施: Human Ghrelin (Drug)
Vertical Sleeve Gastrectomy (VSG) NJ/PO
Patients that are undergoing routine VSG will be studied preoperatively, and at 1 month postoperatively. Each time point will have two study visits with a cross-over design. The first visit at each time point will be randomized to a human ghrelin or a saline infusion, with the alternate infusion at the second visit. At each study visit, an Oral Glucose Tolerance Test (OGTT) will be performed by administering glucose through a nasojejunal (NJ) feeding tube preoperatively and orally (PO) postoperatively.
干预措施: Saline (Drug)
Roux-en-Y Gastric Bypass (RYGB) NJ/PO
Patients that are undergoing routine RYGB will be studied preoperatively, and at 1 month postoperatively. Each time point will have two study visits with a cross-over design. The first visit at each time point will be randomized to a human ghrelin or a saline infusion, with the alternate infusion at the second visit. At each study visit, an Oral Glucose Tolerance Test (OGTT) will be performed by administering glucose through a nasojejunal (NJ) feeding tube preoperatively and orally (PO) postoperatively.
干预措施: Oral Glucose Tolerance Test (OGTT) (Procedure)
Roux-en-Y Gastric Bypass (RYGB) NJ/PO
Patients that are undergoing routine RYGB will be studied preoperatively, and at 1 month postoperatively. Each time point will have two study visits with a cross-over design. The first visit at each time point will be randomized to a human ghrelin or a saline infusion, with the alternate infusion at the second visit. At each study visit, an Oral Glucose Tolerance Test (OGTT) will be performed by administering glucose through a nasojejunal (NJ) feeding tube preoperatively and orally (PO) postoperatively.
干预措施: Human Ghrelin (Drug)
Roux-en-Y Gastric Bypass (RYGB) NJ/PO
Patients that are undergoing routine RYGB will be studied preoperatively, and at 1 month postoperatively. Each time point will have two study visits with a cross-over design. The first visit at each time point will be randomized to a human ghrelin or a saline infusion, with the alternate infusion at the second visit. At each study visit, an Oral Glucose Tolerance Test (OGTT) will be performed by administering glucose through a nasojejunal (NJ) feeding tube preoperatively and orally (PO) postoperatively.
干预措施: Saline (Drug)
Vertical Sleeve Gastrectomy (VSG) PO/PO
Patients that are undergoing routine VSG will be studied preoperatively, and at 1 month postoperatively. Each time point will have two study visits with a cross-over design. The first visit at each time point will be randomized to a human ghrelin or a saline infusion, with the alternate infusion at the second visit. At each study visit, an Oral Glucose Tolerance Test (OGTT) will be performed.
干预措施: Oral Glucose Tolerance Test (OGTT) (Procedure)
Vertical Sleeve Gastrectomy (VSG) PO/PO
Patients that are undergoing routine VSG will be studied preoperatively, and at 1 month postoperatively. Each time point will have two study visits with a cross-over design. The first visit at each time point will be randomized to a human ghrelin or a saline infusion, with the alternate infusion at the second visit. At each study visit, an Oral Glucose Tolerance Test (OGTT) will be performed.
干预措施: Human Ghrelin (Drug)
Vertical Sleeve Gastrectomy (VSG) PO/PO
Patients that are undergoing routine VSG will be studied preoperatively, and at 1 month postoperatively. Each time point will have two study visits with a cross-over design. The first visit at each time point will be randomized to a human ghrelin or a saline infusion, with the alternate infusion at the second visit. At each study visit, an Oral Glucose Tolerance Test (OGTT) will be performed.
干预措施: Saline (Drug)
Roux-en-Y Gastric Bypass (RYGB) PO/PO
Patients that are undergoing routine RYGB will be studied preoperatively, and at 1 month postoperatively. Each time point will have two study visits with a cross-over design. The first visit at each time point will be randomized to a human ghrelin or a saline infusion, with the alternate infusion at the second visit. At each study visit, an Oral Glucose Tolerance Test (OGTT) will be performed.
干预措施: Oral Glucose Tolerance Test (OGTT) (Procedure)
Roux-en-Y Gastric Bypass (RYGB) PO/PO
Patients that are undergoing routine RYGB will be studied preoperatively, and at 1 month postoperatively. Each time point will have two study visits with a cross-over design. The first visit at each time point will be randomized to a human ghrelin or a saline infusion, with the alternate infusion at the second visit. At each study visit, an Oral Glucose Tolerance Test (OGTT) will be performed.
干预措施: Human Ghrelin (Drug)
Roux-en-Y Gastric Bypass (RYGB) PO/PO
Patients that are undergoing routine RYGB will be studied preoperatively, and at 1 month postoperatively. Each time point will have two study visits with a cross-over design. The first visit at each time point will be randomized to a human ghrelin or a saline infusion, with the alternate infusion at the second visit. At each study visit, an Oral Glucose Tolerance Test (OGTT) will be performed.
干预措施: Saline (Drug)
结局指标
主要结局
Change in plasma glucose levels with ghrelin versus saline.
时间窗: 1 month (before and after surgery)
The objective for this protocol is to determine if ghrelin infusion worsens glucose tolerance during jejunal administration of glucose and if the response is difference after bariatric surgery (RYGB or VSG).
次要结局
- Plasma insulin levels(1 month (before and after surgery))
研究者
Naji Abumrad
John L. Sawyers Professor of Surgery
Vanderbilt University Medical Center