The Effect of Dietary Fiber-enriched Cereals on Glycemic Control and Secretion of Gut Hormones
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Area Under the Curve (AUC) of Plasma Total GLP-1 Levels After Intake of the Study Meal
研究概览
简要总结
The aim of this study is to assess whether dietary fiber-enriched cereals effect on postprandial glucose levels and plasma glucagon-like peptide 1 (GLP-1) and/or glucose-dependent insulinotropic polypeptide (GIP) concentration in patients with type 2 diabetes mellitus.
详细描述
Fifteen subjects with type 2 diabetes mellitus will be provided with study meals based on either dietary fiber-enriched cereals or conventional cereals upon two separate admissions in a cross-over fashion. The study meals will be provided at 6 p.m. and 10 p.m. on the day of admission, and 8 a.m. on the next day. A hamburger with coke as mixed meal will be given for lunch at noon on the second day. Blood sampling will be done every 30 minutes from 8 a.m. to 4 p.m. on the second day. The plasma levels of glucose, GLP-1, GIP, insulin, glucagon, and free fatty acid will be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes mellitus
- •HbA1c 6.5~8.5%
- •on life style modification or metformin monotherapy at the time of screening
排除标准
- •on sulfonylurea or insulin therapy at the time of screening
- •allergy to wheat, flour, other cereals or nuts
- •lactose intolerance
- •pregnancy / lactation
结局指标
主要结局
Area Under the Curve (AUC) of Plasma Total GLP-1 Levels After Intake of the Study Meal
时间窗: every 30 minutes from 8 a.m. to noon on the second day
To see the changes in the secretion of GLP-1 with dietary fiber enriched cereal, we will calculate the AUC of the plasma total GLP-1 levels.
次要结局
- AUC of Plasma Insulin Levels After Intake of the Study Meal(every 30 minutes from 8 a.m. to noon on the second day)
- AUC of Plasma Glucagon Levels After Lunch(every 30 minutes from noon to 4 p.m. on the second day)
- AUC of Plasma Glucose Levels After Intake of the Study Meal(every 30 minutes from 8 a.m. to noon on the second day)
- AUC of Plasma Total GLP-1 Levels After Lunch(every 30 minutes from noon to 4 p.m. on the second day)
- AUC of Plasma Glucose Levels After Lunch(every 30 minutes from noon to 4 p.m. on the second day)
- AUC of Plasma Total GIP Levels After Intake of the Study Meal(every 30 minutes from 8 a.m. to noon on the second day)
- AUC of Serum Free Fatty Acid Levels After Intake of the Study Meal(every 30 minutes from 8 a.m. to noon on the second day)
- AUC of Plasma Total GIP Levels After Lunch(every 30 minutes from noon to 4 p.m. on the second day)
- AUC of Serum Free Fatty Acid Levels After Lunch(every 30 minutes from noon to 4 p.m. on the second day)
- AUC of Plasma Glucagon Levels After Intake of the Study Meal(every 30 minutes from 8 a.m. to noon on the second day)
- AUC of Plasma Insulin Levels After Lunch(every 30 minutes from noon to 4 p.m. on the second day)