Effect of Nutritional Products on Metabolic Parameters in Subjects With Type 2 Diabetics
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Positive AUC for plasma glucose concentration
研究概览
简要总结
To compare the postprandial glycemic and insulinemic response of subjects with type 2 diabetes consuming a typical breakfast meal or no breakfast to 10004RF via a meal tolerance test (MTT).
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
- 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
- •between 21 and 75 years of age
- •male or a non-pregnant, non-lactating female, at least 6 weeks postpartum or postmenopausal or surgically sterile
- •BMI is > 18.5 kg/m2 and <35 kg/m2
- •If subject is on a chronic medication such as an anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, they have been on constant dosage for at least two months prior to screening visit.
排除标准
- •Hemoglobin A1c value at screening of greater than or equal to 9%.
- •Uses exogenous insulin or exenatide for glucose control.
- •type 1 diabetes.
- •history of diabetic ketoacidosis.
- •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.
- •active malignancy
- •significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure.
- •end-stage organ failure or is status post organ transplant.
- •history of renal disease.
- •current hepatic disease.
- •history of severe gastroparesis.
- •chronic, contagious, infectious disease
- •taking any herbals, dietary supplements, or medications, other than anti-hyperglycemic medications, that could profoundly affect blood glucose.
- •clotting or bleeding disorders
- •allergic or intolerant to any ingredient found in the study products.
- •habitual user of tobacco products (
研究组 & 干预措施
No breakfast/beverage only
12 fluid ounces made up of one of some combination of the following: decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener
干预措施: No breakfast/beverage only (Other)
Breakfast
1 serving of unflavored instant oatmeal and 12 fluid ounces made up of one of some combination of the following: decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener
干预措施: Breakfast (Other)
10004RF
1 serving (8 fluid ounces) of the experimental beverage and 4 fluid ounces made up of one of some combination of the following: decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener
干预措施: 10004RF (Other)
结局指标
主要结局
Positive AUC for plasma glucose concentration
时间窗: 0 to 180 minutes
次要结局
- Plasma glucose concentrations(0 to 180 minutes)
- Positive AUC for serum insulin concentration(0-180 minutes)