NCT01326299已完成2 期
Post Prandial Glucose Control Proof-of-Principle
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Positive AUC from 0 to 240 minutes for plasma glucose.
研究概览
简要总结
The purpose of this study is to compare the postprandial glycemic response of subjects with type 2 diabetes when consuming a meal along with beverages containing various combinations of nutritional ingredients and fibers versus control beverage.
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
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes
- •between 21 and 75 years of age
- •male or a non-pregnant, non-lactating female, at least 6 weeks postpartum or postmenopausal or surgically sterile
- •BMI is > 18.5 kg/m2 and <35 kg/m2
- •HbA1c < 9.0%
排除标准
- •Subject uses exogenous insulin, exenatide, or sitagliptin phosphate
- •type 1 diabetes.
- •history of diabetic ketoacidosis.
- •current infection
- •active malignancy
- •has had a significant cardiovascular event or history of congestive heart failure.
- •end-stage organ failure or post organ transplant.
- •history of renal disease.
- •hepatic disease.
- •history of gastrointestinal disorders
- •chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
- •taking any herbals, dietary supplements, or medications, other than oral hypoglycemic medications
- •clotting or bleeding disorders.
- •allergic or intolerant to any ingredient found in the study products.
研究组 & 干预措施
Nutritional ingredient
Active Comparator
Dissolve in water and consume with meal
干预措施: Nutritional ingredient (Other)
Carbohydrate
Placebo Comparator
dissolve in water and consume with meal
干预措施: Carbohydrate placebo (Other)
#1 Nutrtitional ingredient + Fiber
Experimental
Dissolve in water and consume with meal
干预措施: #1 Nutritional ingredient +Fiber (Other)
#2 Nutritional ingredient + Fiber
Experimental
Dissolve in water and consume with meal
干预措施: #2 Nutritional ingredient + Fiber (Other)
#3 Nutritional ingredient + Fiber
Experimental
Dissolve in water and consume with meal
干预措施: #3 Nutritional ingredient + Fiber (Other)
结局指标
主要结局
Positive AUC from 0 to 240 minutes for plasma glucose.
时间窗: 0 to 240 minutes
次要结局
- Plasma glucose concentrations(0 to 240 minutes)
研究者
研究点 (1)
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