The Effects of Bariatric Surgeries on Glucose Metabolism
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Insulin levels measured after nutrient ingestion
研究概览
简要总结
The purpose of this study is learn the effect of gastric bypass surgery and sleeve gastrectomy on glucose metabolism mediated by neural and hormonal factors initiated after eating.
详细描述
The purpose of this study is to determine the weight-independent effects of gastric bypass surgery and sleeve gastrectomy surgery on islet cell response after meal ingestion as mediated by hormonal and neural components of the gut. It will also address the differences between the two procedures.
Such information will be critical for the development of novel approaches for treatment of diabetes as well as improvement of glycemic effects of gastric bypass and sleeve gastrectomy in patients with partial diabetes remission or relapse after complete remission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- 是
入选标准
- •Hypoglycemic RYGB patients with documented blood glucose level <50 mg/dl
- •Asymptomatic individuals with bariatric surgery
- •Healthy non-surgical patients with no personal history of diabetes
- •Subjects must physically be able to come to our clinical research center Cedars-Sinai Medical Center
排除标准
- •Active heart, lung, liver, gastrointestinal or kidney disease; unable to give informed consent; pregnancy; uncontrolled high blood pressure or high cholesterol; significant anemia (hemoglobin <11g/dL); prisoners or institutionalized individuals; type 2 diabetes mellitis; development of any serious medical or psychiatric illness during recruitment or studies;
- •RYGB patients will be disqualified if they have gastric outlet obstruction or severe diarrhea.
- •Healthy non-surgical patients with personal history of diabetes
- •For administration of atropine, the following exclusions also apply:
- •History of glaucoma
- •Uncontrolled hypertension (any subjects with BP>140/90 and history of dyslipidemia
- •Taking any medication that might interact with atropine and cannot be stopped will be excluded from the study)
- •Myasthenia gravis
- •Brain pathology
- •Enlarged prostate in men
研究组 & 干预措施
Exendin-(9-39)
To evaluate the role of GLP-1 on glucose metabolism and insulin secretin after glucose and protein ingestion.
干预措施: Exendin-(9-39) (Drug)
Atropine
to evaluate the effect of neural activation on insulin secretion and glucose metabolism
干预措施: Atropine (Drug)
结局指标
主要结局
Insulin levels measured after nutrient ingestion
时间窗: Each study in the protocol is conducted up to seven hours with data collected at intervals specific to the individual study procedure.
次要结局
未报告次要终点