Metabolic Causes of Thrombosis in Type 2 Diabetes - Question 1 - Clinical Trials for Balance, Dizziness in Diabetes

Metabolic Causes of Thrombosis in Type 2 Diabetes - Question 1

This study is currently recruiting participants.
Verified by Vanderbilt University, December 2008
Sponsors and Collaborators: Vanderbilt University
National Heart, Lung, and Blood Institute (NHLBI)

Information provided by: Vanderbilt University
ClinicalTrials.gov Identifier: NCT00574665

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

MedlinePlus related topics: Diabetes
Drug Information available for: Dextrose
U.S. FDA Resources
Study Type:Interventional
Study Design:Prevention, Randomized, Single Blind (Subject), Active Control, Factorial Assignment
Official Title:SCCOR in Hemostatic and Thrombotic Diseases Project 5 - Metabolic Causes of Thrombosis in Type 2 Diabetes

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
Estimated Study Completion Date:February 2011
Estimated Primary Completion Date:February 2011 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental 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

Contacts
Contact: Jennifer Perkins, MD 615-936-1824 jennifer.perkins@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Contact: Jennifer Perkins, MD 615-936-1824 jennifer.perkins@vanderbilt.edu
Principal Investigator: Stephen N. Davis, MD

Sponsors and Collaborators
Vanderbilt University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Stephen N. Davis, MD Vanderbilt University

Responsible Party:Vanderbilt University ( Stephen N. Davis, MD )
Study ID Numbers:IRB#060227-SCCOR-Q1, RFAHL04016
First Received:December 13, 2007
Last Updated:December 4, 2008
ClinicalTrials.gov Identifier:NCT00574665 [history]
Health Authority:United States: Institutional Review Board

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

Study placed in the following topic categories:
Embolism and Thrombosis
Metabolic Diseases
Embolism
Diabetes Mellitus, Type 2
Vascular Diseases
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Thrombosis

Additional relevant MeSH terms:
Cardiovascular Diseases