SCCOR in Hemostatic and Thrombotic Diseases Project 5 - Metabolic Causes of Thrombosis in Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Endothelial function and fibrinolytic balance
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 hyperglycemia and hyperinsulinemia on endothelial function and fibrinolytic balance in Type 2 DM. Our hypothesis is that hyperglycemia, rather than hyperinsulinemia, is responsible for the dysregulation of fibrinolytic balance in diabetics.
详细描述
This study will test the hypothesis that hyperglycemia will impair, while hyperinsulinemia will improve endothelial function and vascular fibrinolytic balance in type 2 DM. As discussed above, their roles in the increased prevalence of thrombotic events occurring in diabetics have not been defined. More recent data supports insulin as profibrinolytic and hyperglycemia to cause endothelial dysfunction. Conclusive studies are lacking in diabetic subjects. Furthermore, preliminary data from this lab indicates that in non-diabetic controls, hyperglycemia results in a prothrombotic state by increasing plasma PAI-1 and reducing tPA levels. The proposed protocol will study the separate and combined effects of hyperglycemia and hyperinsulinemia on endothelial function and fibrinolytic balance in Type 2 DM.
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
- •16 ( 8 female/ 8 male) Type 2 diabetic patients age 18-60 yrs
- •16 ( 8 female/ 8 male) Non-diabetic controls age and weight matched
- •Body mass index 25-52 kgm2
- •Female volunteers of childbearing potential: negative HCG pregnancy test
- •Volunteers over 40 years old: normal baseline ECG
- •For those with type 2 diabetes: HBA1C 6.5-10%
排除标准
- •Prior history of poor health: any current or prior disease condition that alters carbohydrate metabolism and prior cardiac events and/or evidence for cardiac disease
- •Uncontrolled hypertension
- •History of cerebrovascular incidents
- •Pregnancy
- •Subjects unable to give voluntary informed consent
- •Subjects with a recent medical illness
- •Subjects with known liver or kidney disease
- •Subjects on anticoagulant drugs, anemic, or with known bleeding diseases
- •Tobacco Use
结局指标
主要结局
Endothelial function and fibrinolytic balance
时间窗: 2 years
次要结局
未报告次要终点
研究者
Steve Davis
Department Chair
Vanderbilt University