Bariatric Procedures and Changes in Incretins and Gastric Emptying
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Gastric emptying rate after bariatric surgery
研究概览
简要总结
The study evaluates the gastric emptying by scintigraphy in patients that had bariatric surgery (RYGB of gastric sleeve) comparing patients with successful and unsuccessful weight loss and in patients before and after the placement of a duodenal-jejunal bypass liner.
Additional, after bariatric surgery gut hormones that influence the gastric emptying rate are determined.
详细描述
Bariatric surgery reduces stomach volume and passage of foods through the gastrointestinal tract is altered. The satiety level often increases, which is probably caused by gut hormones. Patients response on different bariatric procedures varies widely and it is difficult to predict which patient responds well. Possibly, patients who have successful excess weight loss (EWL) two years after surgery have different gastric emptying rates compared to unsuccessful patients.
Changes in gut hormones after implantation of a duodenal-jejunal bypass liner were demonstrated in other studies. However, gastric emptying before and after placement of this liner is unknown.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Patients must be able to adhere to the study visit schedule and protocol requirements
- •Patients must be able to give informed consent and the consent must be obtained prior to any study procedures
- •Patients who had a follow-up period up till 2 years after bariatric surgery without any complications or
- •Patients are eligible for DJBL implantation
排除标准
- •Binge-eating or associated eating disorder
- •Active drug or alcohol addiction
- •Pregnancy or giving breast feeding
- •Gluten allergy
- •Inability to stop medication that affects the motility of the upper GI tract (anti-cholinergic drugs, prokinetics, theophylline, calcium blocking agents, opioids)
- •Endocrine disease influencing gastric emptying (diabetes mellitus, hyper- or hypothyroidism). Type 2 diabetes mellitus is not an exclusion criterium for patients receiving the DJBL.
结局指标
主要结局
Gastric emptying rate after bariatric surgery
时间窗: 2 years after surgery
In the RYGB and SG group
Change in gastric emptying rate after implantation of DJBL
时间窗: before and 1 month after
In the DJBL group
次要结局
- Quality of life (SF-36, BAROS) after bariatric surgery(2 years after bariatric surgery)
- Change in quality of life (SF-36, BAROS) after DJBL(Before and 1 month after implantation of DJBL)
- Weight loss after bariatric surgery(2 years after bariatric surgery)
- Gut hormone levels after standard meal(2 years after surgery)