Metabolic Causes of Thrombosis in Type 2 Diabetes - Question 1
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.
|Study Design:||Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
|Official Title:||SCCOR in Hemostatic and Thrombotic Diseases Project 5 - Metabolic Causes of Thrombosis in Type 2 Diabetes|
- Endothelial function and fibrinolytic balance [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||October 2006|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Other: Hyperinsulinemic Hyperglycemic Clamp
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.
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Stephen N. Davis, MD||Vanderbilt University|