Comparing Treatment With Food of Small Particle Size and Food of Large Particle Size in Subjects With Diabetic Gastroparesis. Evaluation of Diagnostic Methods. Determination of the Motility of Gastric Emptying After Intervention
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Metabolic Control - HbA1c
研究概览
简要总结
The objective of the study is in subjects with Insulin Treated Diabetes Mellitus type 1 or 2 and gastroparesis:
- validate radiopaque markers with fluoroscopy with gastric scintigraphy method
- study the difference of metabolic control including the frequents of hypoglycaemia, gastrointestinal symptoms, quality of life and nutrition state during dietary treatment of food of small particle size compared with food of large particle size
- validate the radiopaque markers method and measurement of the blood glucose and gastrointestinal symptoms after a test meal, against the gastric scintigraphy
- determine if the function of gastric emptying can be improved after intervention
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
- Single (Participant)
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
- 否
入选标准
- •diabetes type 1 or 2 and gastroparesis
- •must be able to understand oral and verbal instructions
排除标准
- •gastrointestinal surgery
- •other gastrointestinal disease
- •S-Creatinine >150 umol/L
- •mental disease
- •cerebral disease
- •collagen disease
- •untreated endocrine disease
- •anticholinergic drugs
- •psychopharmacologic drugs
- •addiction to drugs as alcohol and narcotics
- •vegetarian
研究组 & 干预措施
Diabetic diet
Control group. Subjects with Insulin Treated Diabetes Mellitus and Gastroparesis. Diet: Food of large particle size during 20 weeks.
干预措施: dietary treatment: food of small particle size (Dietary Supplement)
Diabetic diet
Control group. Subjects with Insulin Treated Diabetes Mellitus and Gastroparesis. Diet: Food of large particle size during 20 weeks.
干预措施: Validate X-ray diagnostic method. (Radiation)
Diabetic diet
Control group. Subjects with Insulin Treated Diabetes Mellitus and Gastroparesis. Diet: Food of large particle size during 20 weeks.
干预措施: Can the motility be improved (Other)
Diabetic diet
Control group. Subjects with Insulin Treated Diabetes Mellitus and Gastroparesis. Diet: Food of large particle size during 20 weeks.
干预措施: postprandial plasma glucose (Biological)
Diet food in small particle size
Intervention group: Subjects with Insulin Treated Diabetes and Gastroparesis. Intervention Diet: Food of small particle size during 20 weeks.
干预措施: dietary treatment: food of small particle size (Dietary Supplement)
Diet food in small particle size
Intervention group: Subjects with Insulin Treated Diabetes and Gastroparesis. Intervention Diet: Food of small particle size during 20 weeks.
干预措施: Validate X-ray diagnostic method. (Radiation)
Diet food in small particle size
Intervention group: Subjects with Insulin Treated Diabetes and Gastroparesis. Intervention Diet: Food of small particle size during 20 weeks.
干预措施: Can the motility be improved (Other)
Diet food in small particle size
Intervention group: Subjects with Insulin Treated Diabetes and Gastroparesis. Intervention Diet: Food of small particle size during 20 weeks.
干预措施: postprandial plasma glucose (Biological)
结局指标
主要结局
Metabolic Control - HbA1c
时间窗: 22 weeks
次要结局
- gastrointestinal symptoms - Questionnaire: Patient Assessment of upper Gastrointestinal Disorders Symptoms, Gastrointestinal Symptom Rating Scale(22 weeks)