Effects and Mechanism of Mosapride Citrate on Diabetic Gastroparesis
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 主要终点
- The improvement of gastric emptying time after taking the medicine
研究概览
简要总结
The purpose of this study is to evaluate the effects and mechanism of mosapride citrate on diabetic gastroparesi.
详细描述
To evaluate the effect of mosapride on DPG by 13 C - octylic acid breath test.
IF C13- octylic acid be absorbed by mucous membrane of small intestine, octylic acid will be oxidated to CO2.Patients eating food containing C13, and then collect their expired gas at 15, 30,45,60,75,90,105,120,150,180,210,240min, analyse the mass of C13 by mass spectrometer, then can calculate the gastric emptying rate.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18≤ age ≤ 75
- •Patients coincided to, the WHO diagnostic criteria for diabetes in 1999 (namely have diabetes symptoms, plasma glucose tendency for 11.1 / L, at any time or fasting plasma glucose tendency for 7.0 / L, or oral glucose tolerance test 2 h plasma glucose levels tendency for 11.1 / L）
- •fasting blood-glucose≤7.0mmol/L and 2h postprandial plasma glucose≤10.0mmol/L
- •Be diagnosed diabetes more than 5 years, blood sugar steady in one month.
- •have the following symptoms for over 4weeks: early satiety ,postprandial fullness ,nausea, vomting,abdominal distension,belching, inappetence, epigastric pain, constipation.
- •Be diagnosed as Delayed Gastric Emptying by C13 breath test.
- •Signed informed consent.
排除标准
- •take gastrointestinal drugs within 2 weeks prior to screening. Or patients with other digestive disease.
- •All patients will be administrated gastroscope in order to exclude stomach or duodenum disease, pyloric obstruction. It's normal in Liver, gallbladder, pancreas,spleen, nephridium by Ultrasound examination .
- •Serious ketoacidosis.
- •History of abdominal operation.
- •Thyroid hypofunction or hyperthyroidism.
- •nervous system disease or autoimmune diseases.
研究组 & 干预措施
mosapride
mosapride 5mg by mouth, 30 minutes before meals, every times one day for 14days
干预措施: Mosapride (Drug)
domperidone
domperidone 10mg by mouth, 30 minutes before meals, every times one day for 14days
干预措施: domperidone (Drug)
结局指标
主要结局
The improvement of gastric emptying time after taking the medicine
时间窗: 2 weeks
Gastric emptying time will be tested by C13 breath test.
次要结局
未报告次要终点
研究者
Liangzhou Wei
Head of departments
Qingdao University