Experimental Medicine Study to Validate the Modified Glucose Disposal Test in Healthy Subjects and Subjects With Type 2 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Glucose (labeled and unlabeled), insulin and c-peptide will be measured to calculate insulin sensitivity, endogenous glucose production and insulin secretion
研究概览
简要总结
Evaluate the modified GDT as a measure of key metabolic characteristics in healthy subjects and those with type 2 diabetes mellitus
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Type 2 diabetes
- •Clinically healthy
- •Drug naive or on a stable dose of metformin monotherapy and/or a secretagogue
排除标准
- •Type 1 Diabetes
- •History of significant heart disease.
- •Bariatric surgery
- •Exposure to fibrates, thiazolidinediones, insulin, exenatide, pramlintide or DPP-IV inhibitors
研究组 & 干预措施
Arm 1
Beta cell function by frequently sampled intravenous glucose tolerance test
干预措施: Insulin, glucose and staple isotopes (Procedure)
Arm 2
Modified glucose disposal test assessment of insulin sensitivity, endogenous glucose production and insulin secretion
干预措施: Insulin, glucose and staple isotopes (Procedure)
Arm 3
Endogenous glucose production and insulin sensitivity by isotope dilution and isoglycemic, heperinsulinemic clamp
干预措施: Insulin, glucose and staple isotopes (Procedure)
结局指标
主要结局
Glucose (labeled and unlabeled), insulin and c-peptide will be measured to calculate insulin sensitivity, endogenous glucose production and insulin secretion
时间窗: within 24 hours
次要结局
- Characterize the patterns of intermediate metabolites in healthy subjects and subjects with type 2 diabetes mellitus(within 24 hours)