NCT00753181已完成3 期
Effects of Nutritional Products on Blood Glucose in Subjects With Type 2 Diabetes
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Average daily blood glucose level
研究概览
简要总结
To evaluate average daily blood glucose in subjects with type 2 diabetes following a Meal Plan including Diabetes-Specific products compared to average daily blood glucose in subjects following their usual diet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •type 2 diabetes
- •HbA1c >6.5% and <11.0%
- •male/non-pregnant, non-lactating female, at least 6 months postpartum
- •if female of childbearing potential, practicing method of birth control
- •Body Mass Index > 18.5 kg/m2 and < 43.0 kg/m
- •weight stable for past two months
- •if on anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, dosage constant for at least two months
排除标准
- •uses injected medications (e.g., insulin, exenatide) for glucose control.
- •history of diabetic ketoacidosis
- •current infection ; inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks
- •active malignancy
- •states he/she has had a significant cardiovascular event < 12 weeks prior to study entry or history of congestive heart failure in the last 12 months.
- •end stage organ failure
- •active metabolic, hepatic, or gastrointestinal disease that may interfere with nutrient absorption, distribution, metabolism, or excretion (such as gastroparesis), excluding diabetes.
- •chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
- •use of herbals, dietary supplements, or medications, other than allowed medications, during past four weeks that could profoundly affect blood glucose.
- •symptomatic in response to blood collection prior to enrollment into this study.
- •clotting or bleeding disorders.
- •non-typical eating pattern
- •is currently using diabetes-specific nutritional product(s)defined as more than one eating occasion per week.
- •engages in strenuous exercise five or more times per week.
研究组 & 干预措施
A1
Experimental
Diabetes Meal Plan with Experimental Diabetes-Specific nutritional shake
干预措施: Nutritional Formula (Other)
A2
Active Comparator
Usual diet
干预措施: Usual diet (Other)
A3
Experimental
Diabetes Meal Plan with Experimental Diabetes-Specific Nutritional Shake, diabetes specific Cereal, and diabetes specific snack bars.
干预措施: Diabetes Meal Plan with experimental diabetes-specific nutritional shake, diabetes specific cereal, and diabetes specific snack bars. (Other)
结局指标
主要结局
Average daily blood glucose level
时间窗: 11 days
次要结局
- Percentage of time in specified glucose ranges; Glycemic excursions; Change in plasma glucose, insulin, free fatty acids, triglycerides, 1,5-anhydroglucitol, and fructosamine; Dietary intake variables(11 days)
研究者
研究点 (2)
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