NCT00974831已完成2 期
Glucose Tolerance in Healthy Overweight Adults
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- The primary variable is the positive area under the curve from 0 to 180 minutes for plasma glucose.
研究概览
简要总结
The primary objective is to compare the postprandial glycemic response of healthy overweight adults after consuming an amino acid drink mix versus a control drink.
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
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fasting blood glucose level of ≥ 70mg/dL and ≤ 125 mg/dL.
- •Subject states that he/she does not have type 1 or 2 diabetes.
- •Subject is overweight as defined as waist circumference ≥ 101 cm (40 inches) male; ≥ 88 cm (35 inches) female.
- •Subject's BMI is ≥ 25 kg/m
- •Subject's blood pressure is < 140 mm Hg systolic and < 90 mm Hg diastolic.
- •Subject is between 20 and 45 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 birth control
- •If subject is on a chronic medication such as a thyroid medication or hormone therapy, has been on constant dosage for at least two months prior to screening visit.
排除标准
- •Subject is eating a low carbohydrate diet such as Atkins, Zone, or South Beach diet plan.
- •Subject states that he/she has 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.
- •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 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 during the past four weeks prior to screening visit that could profoundly affect blood glucose.
- •Subject has taken/is currently taking any herbals, dietary supplements, or medications during the past four weeks prior to screening visit to control hypertension or cholesterol.
- •Subject states that he/she has clotting or bleeding disorders.
结局指标
主要结局
The primary variable is the positive area under the curve from 0 to 180 minutes for plasma glucose.
时间窗: 0-180 minutes
次要结局
- Plasma glucose, insulin, C-peptide, free fatty acids, and glucagon concentration data over time(0-180 minutes)
研究者
研究点 (2)
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