Effects of Itopride Hydrochloride on Gastric Emptying, Glycaemia and "Meal-related" Symptoms in Patients With Type 1 and Type 2 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Gastric emptying assessment
研究概览
简要总结
Itopride is a new compound that is already marketed in Japan and in some countries of Eastern Europe under the name of Ganaton. It is used to treat symptoms associated with gastroparesis. Due to inadequate gastric emptying, these patients often have symptoms of bloating, nausea and vomiting following ingestion of a meal. The goal of this study is to evaluate the effects of Itopride on gastric motor function and glycemia in patients with diabetes.
详细描述
This is a mechanistic study evaluating in a cross-over design the effects of Itopride hydrochloride.
The primary objective of this study is to evaluate the acute effects of itopride hydrochloride (200 mg three times daily) on gastric emptying of solid and liquid meal components in patients with type 1 and type 2 diabetes mellitus. Secondary objectives are to evaluate the effects of itopride hydrochloride on the glycaemic response to a meal, "meal-related" upper gastrointestinal symptoms and intragastric meal distribution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type-1 and Type-2 diabetic patients
- •18 to 65 years old
- •Glycated haemoglobin level (HbA1c) below 9%
- •Body mass index (BMI) between 18 and 35 kg/m2
排除标准
- •Use of medications potentially influencing upper gastrointestinal motility or appetite within one week of the study (e.g. prokinetic drugs, macrolide antibiotics)
- •Exposure to radiation for research purposes during the previous 12 months
研究组 & 干预措施
Itopride
干预措施: Itopride (Drug)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Gastric emptying assessment
时间窗: weekly
次要结局
- Glycemia, relief of upper gastrointestinal symptoms, intragastric meal distribution(weekly)