NCT01021462已完成1 期
An Open-Label, 2-Period, Pilot Study in Healthy Male Subjects to Evaluate the Use of a Graded Infusion of Intravenous Glucose in the Assessment of Insulin Secretion Rates
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- proper implementation and tolerability of a grade glucose infusion using D20 intravenous infusion measured by glucose, insulin and C-peptide levels
研究概览
简要总结
A two period pilot study to determine if a graded glucose infusion using a glucose (20% dextrose [D20]) intravenous infusion can be properly implemented and will be well tolerated in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subject is in good health
- •Subject is a non-smoker
排除标准
- •Subject has a history of hypertension requiring treatment
- •Subject has a history of cancer
- •Subject's parents of siblings have a history of type 2 diabetes
- •Subject is unable to refrain from the use of any prescription or non-prescription medication
- •Subject consumes excessive amounts of alcohol or caffeine
- •Subject has had major surgery, donated blood or participated in another investigational study in the past 4 weeks
结局指标
主要结局
proper implementation and tolerability of a grade glucose infusion using D20 intravenous infusion measured by glucose, insulin and C-peptide levels
时间窗: 0-160 minutes after start of infusion
次要结局
- beta-cell glucose sensitivity (slope of the relationship between insulin secretion rate and glucose)(0-160 minutes after start of infusion)
研究者
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