The Effect of Bariatric Surgery on Metabolism, the Metabolome and the Microbiome in Patients With Type 2 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Glucose AUC
研究概览
简要总结
What are the benefits of undergoing Roux-en-Y gastric bypass surgery in improving type 2 diabetes outside of weight loss alone?
详细描述
Roux-en-y gastric bypass (RYGB) surgery leads to improvements in diabetes that occurs even before any significant weight loss is seen. What are the reasons for this? There is evidence in animals that changes in the composition of gut bacteria after RYGB may be responsible for improvements in how glucose is metabolized in the body. The study aims to correlate changes in the bacterial composition of the gut that occurs after surgery with improvements in glucose metabolism in people with type 2 diabetes. The investigators will do this by using validated methods to measure glucose metabolism and cutting edge technology to analyze the gut microbiome. A parallel group of patients with similar weight, height and age will undergo caloric restriction alone to mimic weight loss seen after RYGB. Participants will also undergo similar glucose metabolism studies and analysis of their gut bacterial composition. Thus, any difference seen between groups can be attributed to the surgery itself and may lead to identification of novel therapeutic options for diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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 RYGB surgery.
- •Type 2 Diabetes Mellitus or impaired fasting glucose with BMI >35 AND not interested in surgery but are interested in supervised caloric restriction.
排除标准
- •Previous treatment with thiazolidinediones.
- •Chronic antibiotic therapy.
- •Active microvascular or macrovascular complications of diabetes.
研究组 & 干预措施
Roux-en-Y Gastric Bypass (RYGB)
Subjects between the ages of 20-65 years of age seen for weight management in the Nutrition Clinic at Mayo Clinic, who have been approved for RYGB.
干预措施: Roux-en-Y Gastric Bypass (RYGB) (Procedure)
Caloric restriction
Subjects between the ages of 20-65 years of age, with diagnosis of Type 2 diabetes mellitus or impaired fasting glucose. Subjects will undergo caloric restriction alone to mimic weight loss seen after gastric bypass surgery.
干预措施: Caloric Restriction (Behavioral)
Exendin-9,39
Four subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of Exendin-9,39 or normal saline.
干预措施: Exendin-9,39 (Drug)
Normal Saline
Four subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of Exendin-9,39 or normal saline.
干预措施: Normal Saline (Drug)
结局指标
主要结局
Glucose AUC
时间窗: 0 to 360 minutes post-meal at Baseline and 12 weeks post-intervention
Area under the curve calculated from Oral Glucose Tolerance Test
Changes in the Gut Microbiome Following RYGB or Caloric Restriction
时间窗: baseline and 12 weeks post intervention
Stool sample collection for gut microbiome analysis
Peak Glucose
时间窗: 4 weeks post intervention
Blood sample taken after a meal.
Fasting Glucose
时间窗: 4 weeks post intervention
Blood sample taken after an overnight fast.
次要结局
未报告次要终点
研究者
Meera Shah, M.B., Ch.B.
Assistant Professor of Medicine
Mayo Clinic