Restoration of Beta Cell Function and Cardiovascular Parameters in Relation to Adipoinsular and Enteroinsular Axes After Gastric Bypass Surgery in Severely Obese Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Acute insulin response (AIR) to glucose during IVGTT will be used as a primary variable characterizing the beta cell function
研究概览
简要总结
Bariatric operations such as the gastric bypass procedure provide a unique in vivo model of improvement of pathological beta cell function. The presented double-centre study aims to comprehensively investigate different aspects of beta cell function in patients with type 2 diabetes (T2DM) with a wide range of disease duration after gastric bypass. In parallel, our project will address the aspects of changes in enteroinsular and adipoinsular axes as well as the early and late changes of other defined parameters after gastric bypass surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 years
- •indication forbariatric surgery or non-bariatric abdominal surgery
排除标准
- •Pregnancy
研究组 & 干预措施
T2DM patients before gastric bypass surgery
oral glucose tolerance test , botnia clamp, preoperative as well as 10 days postoperative and 1 year postoperative, gastric bypass surgery.
干预措施: gastric bypass surgery (Procedure)
Non-diabetic patient before gastric bypass surgery
oral glucose tolerance test , botnia clamp, preoperative as well as 10 days postoperative and 1 year postoperative, gastric bypass surgery.
干预措施: gastric bypass surgery (Procedure)
non diabetic patients, non-bariatric abdominal surgery
oral glucose tolerance test , botnia clamp, elective laparoscopic abdominal surgery.
干预措施: abdominal surgery (Procedure)
severely obese T2DM patients following a very low caloric diet
oral glucose tolerance test , botnia clamp, before as well after following a very low caloric diet. Very low caloric diet.
干预措施: very low caloric diet (Behavioral)
结局指标
主要结局
Acute insulin response (AIR) to glucose during IVGTT will be used as a primary variable characterizing the beta cell function
时间窗: 10 days after gastric bypass
次要结局
- OGTT calculations and modelling describing beta cell response to oral glucose load; Insulin and C-peptide areas under the curve (AUCs) during OGTT quantifying the incretin effect.(10 days after gastric bypass)
- • Plasma concentrations and adipose tissue expression of selected adipokines and inflammatory cytokines characterizing the adipoinsular axis(10 days after gastric bypass)
研究者
Bernd Schultes
Head of Interdisciplinary Obesity Center
Cantonal Hospital of St. Gallen