NCT00797069已完成3 期
Comparison of Nutritional Products for People With Type 2 Diabetes
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 6
- 主要终点
- To compare the postprandial glycemic response of patients with type 2 diabetes consuming single servings of a standard liquid nutrition product and two diabetes-specific liquid nutrition products.
研究概览
简要总结
Compare the glycemic and insulinemic responses of a standard nutritional product with two diabetes-specific nutritional products in patients with type 2 diabetes.
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
- •Subject states that he/she has type 2 diabetes (as evidenced by use of oral hypoglycemic medication for at least two months).
- •Subject is between 18 and 75 years of age, inclusive.
- •Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit.
- •If female is of childbearing potential, is practicing a method of birth control.
- •Subject's BMI is > 18.5 kg/m2 and < 35 kg/m
- •If on a chronic medication such as anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, subject has been on constant dosage for at least two months prior to screening visit.
排除标准
- •Subject uses exogenous insulin for glucose control.
- •Subject states that he/she has type 1 diabetes.
- •Subject states that he/she has a history of diabetic ketoacidosis.
- •Subject takes an alpha-glucosidase inhibitor.
- •Subject states that he/she has a current infection ; has had inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks prior to screening visit.
- •Subject states that he/she has an active malignancy (excluding the following dermal malignancies: basal cell carcinoma, squamous cell carcinoma, carcinoma in-situ of the cervix).
- •Subject states that he/she has had a significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure.
- •Subject states that he/she has end stage organ failure or is status post organ transplant.
- •Subject states that he/she has a history of renal disease.
- •Subject states that he/she has current hepatic disease.
- •Subject states that he/she has a history of severe gastroparesis.
- •Subject states that he/she has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
- •Subject has taken/is currently taking any herbals, dietary supplements, or medications, other than oral hypoglycemic medications, during the past four weeks prior to screening visit that could profoundly affect blood glucose.
- •Subject states that he/she has clotting or bleeding disorders.
- •Subject is known to be allergic or intolerant to any ingredient found in the study products.
结局指标
主要结局
To compare the postprandial glycemic response of patients with type 2 diabetes consuming single servings of a standard liquid nutrition product and two diabetes-specific liquid nutrition products.
时间窗: Three crossover periods
次要结局
- To compare the postprandial insulinemic response of patients with type 2 diabetes consuming single servings of a standard liquid nutrition product and two diabetes-specific liquid nutrition products.(Three crossover periods)
研究者
研究点 (6)
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