Metabolic Causes of Thrombosis in Type 2 Diabetes - Question 1

Type 2 Diabetes Clinical Trial

Official title:

SCCOR in Hemostatic and Thrombotic Diseases Project 5 - Metabolic Causes of Thrombosis in Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00574665
• Other study ID #: IRB#060227-SCCOR-Q1
• Secondary ID: RFAHL04016
• Status: Completed
• Phase: N/A
• First received: December 13, 2007
• Last updated: December 10, 2014
• Start date: October 2006
• Est. completion date: December 2010

Study information

• Verified date: December 2014
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• Hyperinsulinemic Hyperglycemic Clamp
Glucose Clamp

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial function and fibrinolytic balance		2 years	No