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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
  Purpose

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.


Condition Intervention
Type 2 Diabetes
 Other: Hyperinsulinemic Hyperglycemic Clamp

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Endothelial function and fibrinolytic balance [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: October 2006
Study Completion Date: December 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Other: Hyperinsulinemic Hyperglycemic Clamp
Glucose Clamp

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00574665

Locations
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Stephen N. Davis, MD Vanderbilt University
  More Information

No publications provided

Responsible Party: Stephen N. Davis, MD, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00574665     History of Changes
Other Study ID Numbers: IRB#060227-SCCOR-Q1, RFAHL04016
Study First Received: December 13, 2007
Last Updated: December 16, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Type 2 Diabetes
Endothelial Function
Fibrinolytic Balance

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Thrombosis
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013