NCT00499148已完成2 期
Effect of Herbal Extract on Metabolic Parameters in Subjects With Type 2 Diabetes
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 3
- 主要终点
- positive AUC for plasma glucose
研究概览
简要总结
The purpose of the study was to evaluate the effect of an herbal extract on postprandial glycemia following a meal.
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
- Double
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
- •Between 18 and 75 years of age
- •Male or non-pregnant, non-lactating female, at least 6 weeks postpartum
- •If of childbearing potential, is practicing birth control
- •BMI is more than or equal to 18kg/m2 and less than or equal to 35kg/m2
- •If on anti-hyperglycemic, anti-hypertensive, lipid-lowering, or thyroid medications or hormone therapy, has been on constant dosage for at least 3 months prior to screening visit
排除标准
- •Uses insulin for glucose control or has type 1 diabetes
- •History of diabetic ketoacidosis.
- •Current infection; surgery or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks.
- •Active malignancy
- •Significant cardiovascular event less than or equal to 6 months prior to screening visit or history of congestive heart failure
- •End state organ failure or status post organ transplant
- •History of renal disease
- •Current hepatic disease
- •History of severe gastroparesis
- •Has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV
- •Currently taking herbals, dietary supplements, or medications, other than anti-hyperglycemic medications, during the past 4 weeks that could profoundly affect blood glucose
- •Clotting or bleeding disorders
- •Allergic or intolerant to any ingredient found in the study products
结局指标
主要结局
positive AUC for plasma glucose
时间窗: 4 hours
次要结局
- positive AUC for serum insulin; adjusted peak values for plasma glucose and serum insulin; baseline plasma glucose and serum insulin concentrations; adjusted values for plasma glucose and serum insulin at individual postprandial time points.(4 hours)
研究者
研究点 (3)
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