NCT00520065已完成2 期
Comparison of Nutritional Products for People With Type 2 Diabetes
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Positive area under the curve (AUC) for plasma glucose and mean glucose level
研究概览
简要总结
Part A: To compare the glucose and insulin responses of a standard tube feeding product to that of a diabetes-specific tube feeding product in individuals with type 2 diabetes.
Part B: To compare the glucose response of a standard tube feeding product to that of a diabetes-specific tube feeding product when consumed by individuals with type 2 diabetes as a sole source of nutrition.
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 form
- •Type 2 diabetes
- •18 to 75 years of age
- •Male or non-pregnant, non-lactating female, at least 6 weeks postpartum
- •If female is of childbearing potential, is practicing birth control
- •BMI greater than or equal to 18.5 kg/m2 and less than 40.0 kg/m2
- •Medications, such as antihyperglycemic or thyroid medications or hormone therapy, have been maintained at a constant dosage for at least two months prior to screening visit
排除标准
- •Uses exogenous insulin for glucose control
- •Type 1 diabetes
- •History of diabetic ketoacidosis
- •Current infection; has received corticosteroid treatment in the last 3 months, or has had surgery or received antibiotics in the last 3 weeks
- •Active malignancy
- •Significant cardiovascular event less than 12 weeks prior to study entry
- •End stage organ failure or is status post organ transplant
- •Has an active metabolic, hepatic, or gastrointestinal disease that may interfere with nutrient absorption, distribution, metabolism, or excretion excluding diabetes
- •Chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV
- •Taking any herbals, dietary supplements or medications, other than antihyperglycemic medications during the past four weeks that could profoundly affect blood glucose
- •Fainted or experienced other adverse reactions in response to blood collection prior to this study
- •Has clotting or bleeding disorders
- •Allergic or intolerant to any ingredient found in the study products
- •Participant in a concomitant trial that conflicts with this study
结局指标
主要结局
Positive area under the curve (AUC) for plasma glucose and mean glucose level
时间窗: 240 minutes
次要结局
- Adjusted peak values for plasma glucose and serum insulin concentrations and positive AUC for serum insulin concentration(240 minutes)
研究者
研究点 (2)
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