Mechanisms of Pro-Thrombosis in Diabetes Mellitus -- Ancillary to BARI 2D

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00041405
Recruitment Status : Completed
First Posted : July 9, 2002
Last Update Posted : May 13, 2016
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary:
To determine the effect of the method of hyperglycemic management on pro- thrombotic potential in diabetic subjects.

Condition or disease
Cardiovascular Diseases Heart Diseases Diabetes Mellitus, Non-insulin Dependent Coronary Disease Thrombosis Diabetes Mellitus

Detailed Description:


Cardiovascular disease is the leading cause of death in patients with diabetes. The BARI 2D study is designed to determine the potential value of specific treatment regimens for those with diabetes and will test the hypothesis that "with a target HbA1C of less than 7.5%, a strategy of hyperglycemic management directed at insulin sensitization results in lower 5 year mortality compared to a strategy of insulin provision." This ancillary study is designed to provide mechanistic insight into potential benefits derived from two different treatment strategies employed by characterizing the thrombotic potential in those patients assigned to the aggressive medical management strategy and long-range goal is to demonstrate that treatment of diabetes with regimens that reduce thrombotic potential decreases cardiovascular risk. The results of this ancillary study should help to define the extent to which specific regimens diminish the pro-thrombotic state.

The study is in response to an initiative on Ancillary Studies in Heart, Lung, and Blood Disease Trials released in June, 2000.


Thrombotic potential will be assessed by determination of both platelet reactivity and thrombin generation and activity. Preliminary studies have found that patients with diabetes have increased coronary intervention. Further, thrombin generation and activity is increased in diabetic subjects. Preliminary evidence suggests that treatment with an insulin-sensitizing regimen reduces platelet reactivity, thrombin generation and thrombin activity. The BARI 2D study is ideally suited for determination of the effect of the method of glycemic control on pro-thrombotic potential. In aim 1 the investigators will determine platelet reactivity before and during the first year of treatment in patients randomized to medical treatment and randomized also to either an insulin-sensitizing regimen or an insulin-providing regimen. They will use a flow cytometry-based assay of platelet function that they have developed and validated. In aim 2 they will determine the effect of treatment on thrombin generation and activity in the same group of patients. Thrombin generation will be determined by measuring the concentration in blood of a cleavage fragment (prothrombin fragment 1+2). Thrombin activity will be determined by measuring the concentration in blood of a second cleavage fragment (fibrinopeptide A). The results of the studies will determine the effect of the method of hyperglycemic management on pro-thrombotic potential. Further, these results will define the importance of prothrombotic potential in diabetic subjects while potentially identifying new therapeutic targets in patients with diabetes and other insulin resistant states.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Study Type : Observational
Study Start Date : July 2001
Actual Study Completion Date : June 2005

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Ages Eligible for Study:   up to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
No eligibility criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00041405

Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
OverallOfficial: David Schneider University of Vermont & State Agricultural College

Publications: Identifier: NCT00041405     History of Changes
Other Study ID Numbers: 1179
R01HL069146 ( U.S. NIH Grant/Contract )
First Posted: July 9, 2002    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: July 2005

Additional relevant MeSH terms:
Diabetes Mellitus
Cardiovascular Diseases
Heart Diseases
Coronary Disease
Coronary Artery Disease
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Embolism and Thrombosis
Vascular Diseases
Myocardial Ischemia
Arterial Occlusive Diseases