A Randomized Clinical Trial to Study Glucose Dependent Insulin Secretion Methodologies in Healthy Lean Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 主要终点
- Change From Baseline in Insulin Secretion Rate (ISR) Normalized to Ambient Plasma Glucose
研究概览
简要总结
This study will compare graded glucose infusion (GGI) to the hyperglycemic clamp (HGC) for assessment of glucose-dependent insulin secretion (GDIS) using exenatide as a probe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
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 has a Body Mass Index (BMI) of less than or equal to 26 kg/m2 at screening
- •Subject is judged to be in good health
- •Subject has been a nonsmoker for at least 3 months
- •Subject is willing to avoid strenuous physical activity for the duration of the study
排除标准
- •Subject has a history of high blood pressure requiring treatment
- •Subject has a history of diabetes or a family history of diabetes mellitus
- •Subject is unable to discontinue all prescription and non-prescription drugs for duration of study
- •Subject consumes more than 3 alcoholic beverages per day
- •Subject consumes more than 6 servings of caffeinated beverages per day (1 serving = 120mg caffeine)
- •Subject has had major surgery or has donated or loss 1 unit of blood within 4 weeks of screening
- •Subject has multiple and/or severe allergies to foods or drugs
- •Subject is a regular user of illegal drugs
- •Subject is unwilling or unable to consume the standardized meals during the study and/or is on a carbohydrate restricted diet
结局指标
主要结局
Change From Baseline in Insulin Secretion Rate (ISR) Normalized to Ambient Plasma Glucose
时间窗: Steady-state of HGC: 90 - 120 minutes post dose; highest glucose infusion rate of GGI: 120 - 160 minutes post dose
Comparison of Glucose Dependent Insulin Secretion (GDIS) measured after HGC at steady-state to GDIS measured after GGI at the highest glucose infusion rate. Insulin Secretion Rate (ISR)/ Blood Glucose (BG)
Change From Baseline in Insulin Concentration
时间窗: Pre and Post glucose infusion
Change From Baseline in C-peptide Concentration
时间窗: Pre and Post glucose infusion
次要结局
未报告次要终点