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Metabolic Causes of Thrombosis in Type 2 Diabetes - Question 1

NCT ID: NCT00574665

Last Updated: 2014-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2010-12-31

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes

Keywords

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Type 2 Diabetes Endothelial Function Fibrinolytic Balance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Group Type EXPERIMENTAL

Hyperinsulinemic Hyperglycemic Clamp

Intervention Type OTHER

Glucose Clamp

Interventions

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Hyperinsulinemic Hyperglycemic Clamp

Glucose Clamp

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Steve Davis

Department Chair

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stephen N. Davis, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

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Vanderbilt University

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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RFAHL04016

Identifier Type: -

Identifier Source: secondary_id

IRB#060227-SCCOR-Q1

Identifier Type: -

Identifier Source: org_study_id