Bariatric Surgery for the Treatment of Type 2 Diabetes - Clinical Effects and Underlying Mechanisms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change from Baseline of Glucose Turnover
研究概览
简要总结
The main purpose of this project is to further explore the metabolic effects and the mechanisms underlying the improvement in glucose homeostasis following bariatric surgery. The project will involve both prevention and treatment of Type 2 Diabetes (T2D), and both pre-diabetic as well as diabetic subjects with obesity will be included. This part of the project focuses on patients with manifest T2D and they will be assigned to surgical and non-surgical intervention, respectively, in a strictly controlled and randomized manner.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged 18-60 years
- •Type 2 Diabetes Mellitus with duration of no more than 10 years, treated with 0-3 oral anti-diabetic drugs or Glucagon-like peptide-1 (GLP-1) analog.
排除标准
- •Pregnant or planning to be pregnant during the study.
- •Known or suspected history of significant drug abuse.
- •History of alcohol abuse or excessive intake of alcohol as judged by investigator.
- •History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator
- •Sleep apnea
- •Any previous serious cardiovascular event, stroke , acute myocardial infarction.
- •Diabetes complications : proliferative retinopathy, maculopathy, chronic renal failure stadium 3 with an Estimated Glomerular Filtration Rate (eGFR) <60, foot ulcers, symptomatic neuropathy
- •Medications within 3 months : Insulin, Thiazolidinediones
- •Any other condition with in the opinion of the investigator would render the patient unsuitable for inclusion in the study and /or for the patients safety
- •Judgment by the investigator that the subject should not participate in the study if considers subject unlikely to comply with study procedures, restrictions and requirements.
结局指标
主要结局
Change from Baseline of Glucose Turnover
时间窗: 1 month after surgery
Change from Baseline of beta cell function
时间窗: 1 month after surgery
Change from Baseline of homeostatic model assessment (HOMA) for insulin resistance
时间窗: 1 month after surgery
次要结局
- Change from Baseline of beta cell function(24 months after surgery)
- Change from Baseline of Glucose Turnover(24 months after surgery)
- Change from Baseline of homeostatic model assessment (HOMA) for insulin resistance(24 months after surgery)