Detailed Assessment of Gastric Functions in Patients With Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 5
- 主要终点
- Pyloric distensibility
研究概览
简要总结
This is a comprehensive pathophysiological study assessing various gastric functions in patients with diabetes mellitus. The investigators aim to examine the stomach with various measurement devices to gain information about its different functions and malfunctions. After the initial measurements, the examinations will be repeated after a year in each patient. Changes in the measurement values will be examined and their relations to each other and to the overall health of the patients will be investigated.
For example it is hypothesised that diabetic patients also suffering from functional dyspepsia or gastroparesis will also show some changes in the function of the pyloric muscle.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Pyloric distensibility
时间窗: At baseline and after 12 months
Pyloric distensibility measured by impedance planimetry (EndoFLIP device)
次要结局
- Gastric emptying by scintigraphy(At baseline and after 12 months)
- GCSI score(At baseline and after 6 and 12 months)
- PAGI-SYM score(At baseline and after 6 and 12 months)
- PAGI-QoL score(At baseline and after 6 and 12 months)
- Gastric emptying by breath test(At baseline and after 12 months)
- Electrogastrography(At baseline and after 12 months)
- Autonomic function testing(At baseline and after 12 months)
研究者
Doc. (Ass. prof.) Jan Martinek, MD, PhD, AGAF
Prof. Jan Martínek, MD, PhD, AGAF
Institute for Clinical and Experimental Medicine