NCT00540488已完成3 期
Randomized, Double Blind, Three Way Crossover Comparison of Glucose and Insulin Responses During a Meal Glucose Tolerance Test in Subjects With Type 2 Diabetes Consuming Disease-Specific Versus Standard Nutritional Formula
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 4
- 主要终点
- Adjusted area under the curve (adj-AUC) of glucose response
研究概览
简要总结
To measure and compare the glycemic and insulinemic responses of subjects consuming a standard and two diabetes-specific products.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed and dated informed consent
- •18-75 years of age
- •history of type 2 diabetes
- •males and non-pregnant, non-lactating females
排除标准
- •subject uses insulin for glucose control
- •significant cardiovascular event <12 weeks prior to study entry
- •active malignancies
- •history of end stage renal disease
- •history of organ transplant
- •current hepatic disease
- •intervention for HIB
- •takes niacin
- •history of gastroparesis
- •active disease that may interfere with nutrient intake
- •allergy or intolerance to ingredients in the study products
结局指标
主要结局
Adjusted area under the curve (adj-AUC) of glucose response
时间窗: 0-240 minutes
次要结局
- Adjusted peak for glucose and insulin response;peak time for glucose and insulin response; Adj-AUC for insulin response; change in glucose and insulin; subjective gastrointestinal tolerance(0 - 240 minutes)
研究者
研究点 (4)
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