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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00574665

Enrollment

Registered

2007-12-17

Start date

2006-10-31

Completion date

2010-12-31

Last updated

2014-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes, Endothelial Function, Fibrinolytic Balance

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.

Interventions

OTHERHyperinsulinemic Hyperglycemic Clamp

Glucose Clamp

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Endothelial function and fibrinolytic balance	2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026