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Metabolic Causes of Thrombosis in Type 2 Diabetes - Question 1

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00574665
First received: December 13, 2007
Last updated: December 16, 2010
Last verified: December 2010
History of Changes

December 13, 2007
December 16, 2010
October 2006
December 2009   (final data collection date for primary outcome measure)
Endothelial function and fibrinolytic balance [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00574665 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Metabolic Causes of Thrombosis in Type 2 Diabetes - Question 1
SCCOR in Hemostatic and Thrombotic Diseases Project 5 - Metabolic Causes of Thrombosis in Type 2 Diabetes

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.

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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Type 2 Diabetes
Other: Hyperinsulinemic Hyperglycemic Clamp
Glucose Clamp
Experimental: 1
Intervention: Other: Hyperinsulinemic Hyperglycemic Clamp
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
December 2010
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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%

Exclusion Criteria:

  • 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
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00574665
IRB#060227-SCCOR-Q1, RFAHL04016
No
Stephen N. Davis, MD, Vanderbilt University
Vanderbilt University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Stephen N. Davis, MD Vanderbilt University
Vanderbilt University
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP