Metabolic Causes of Thrombosis in Type 2 Diabetes - Question 4
Hypoglycemia (low blood glucose level) occurs frequently in intensively treated patients with diabetes. Although hypoglycemia was thought to occur almost exclusively in T1DM, with the advent of improved metabolic control in T2DM, the incidence of hypoglycemia is rising in these patients. Therefore in this application, we will test the novel hypothesis that prior hypoglycemia will result in (cardiovascular complications) during subsequent hypoglycemia.
|Study Design:||Allocation: Randomized
Intervention Model: Single Group 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|
- Percent Changes in Endothelial Function as Measured by Flow Mediated Dilation by 2D Doppler Ultrasound [ Time Frame: 6 hours ] [ Designated as safety issue: No ]A measure of the baseline arterial dilation is compared to the post intervention measure of dilation of the brachial artery.
|Study Start Date:||May 2007|
|Study Completion Date:||April 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Experimental: Glucose clamp
Day 1 euglycemia, day 2 hypoglycemia
Other: Hyperinsulinemic Hypoglycemic Clamp
hyperinsulinemic glucose clamp separated by 8 weeks
This study will test the hypothesis that 1) hypoglycemia causes a prothrombotic state and defective endothelial function and 2) episodes of repeated hypoglycemia will result in greater impairments of endothelial function and an increased prothrombotic tendency. Preliminary data in healthy men demonstrates that hypoglycemia can dramatically increase PAI-1 levels and the PAI-1 to tPA ratio, thereby creating a prothrombotic state. Whether this also occurs in type 2 DM patients is unknown. Furthermore, the effects of hypoglycemia on endothelial function in T2DM are also unknown.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00574340
|United States, Maryland|
|University of Maryland, Baltimore|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Stephen N. Davis, MD||University of Maryland, Baltimore County|