Metabolic Causes of Thrombosis in Type 2 Diabetes Mellitus, Question 3
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Percent change in flow mediated dilation of brachial artery
研究概览
简要总结
The purpose of this study is to learn more about why patients with diabetes have increased heart attacks, strokes and other illnesses due to blood clots causing blockage of a blood vessel. The proposed protocol will study the separate and combined effects of high glucose and high fats on certain cardiovascular responses in Type 2 DM.
详细描述
Currently 75-80% of diabetes mellitus (DM) patients die due to thrombotic causes. Data from the Centers for Disease Control and Prevention released in 2000 indicated that mortality due to coronary artery disease is decreasing except in individuals with diabetes. Clearly the disordered metabolism, which includes abnormal metabolism of fats resulting in higher triglyceride and free fatty acid blood levels, occurring in diabetes predisposes these individuals to increased thrombotic events. Unless the underlying mechanisms responsible for these events can be identified, there will be an unprecedented number of diabetic patients suffering thrombotic episodes in the next 10 years.
The specific aims of this study are to determine the effects of elevated free fatty acids and hyperglycemia (high glucose)on endothelial function and thrombolytic balance in patients with type 2 diabetes, and to determine the effects of increased insulin in this setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Euinsulinemic (low insulin infusion) Euglycemic (normal blood glucose levels) glucose clamp with lipid (fat) infusion
干预措施: euinsulinemic euglycemic glucose clamp (Procedure)
2
Euinsulinemic Hyperglycemic (high glucose levels) glucose clamp with lipid infusion
干预措施: euinsulinemic hyperglycemic glucose clamp (Procedure)
3
Hyperinsulinemic (High dose insulin) euglycemic glucose clamp with lipid infusion
干预措施: Hyperinsulinemic euglycemic glucose clamp (Procedure)
4
Hyperinsulinemic hyperglycemic (high glucose level) glucose clamp with lipid infusion
干预措施: Hyperinsulinemic hyperglycemic glucose clamp (Procedure)
结局指标
主要结局
Percent change in flow mediated dilation of brachial artery
时间窗: 4 hours
次要结局
- Change in Lipid measures(4hours)
研究者
Stephen N. Davis, MBBS
Professor
University of Maryland, Baltimore