Metabolic Causes of Thrombosis in Type 2 Diabetes - Question 1

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Other: Hyperinsulinemic Hyperglycemic Clamp

• Registration Number: NCT00574665
• Lead Sponsor: Vanderbilt University

Brief 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.

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.

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2007-12-13
• Study First Submitted QC: 2007-12-13
• Study First Posted: 2007-12-17
• Primary Completion: 2009-12
• Study Completion: 2010-12
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-10
• Last Update Posted: 2014-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
1	Hyperinsulinemic Hyperglycemic Clamp	-

Primary Outcome Measures

Name	Time	Method
Endothelial function and fibrinolytic balance	2 years

Trial Locations

Locations (1)

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States