Advertisement

Topics

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

2014-08-27 03:55:58 | BioPortfolio

Summary

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

Description

BACKGROUND:

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.

DESIGN NARRATIVE:

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.

Study Design

Observational Model: Defined Population

Conditions

Cardiovascular Diseases

Status

Completed

Source

National Heart, Lung, and Blood Institute (NHLBI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:55:58-0400

Clinical Trials [1196 Associated Clinical Trials listed on BioPortfolio]

Cardiovascular Diseases in HIV-infected Subjects (HIV-HEART Study)

Human immunodeficiency virus (HIV) infection has been associated with a variety of cardiovascular diseases. Even most industrialised countries exhibit a growing and aging population of HIV...

The Effects of Aerobic Exercise in Microvascular Endothelium Function in Patients With Cardiovascular Diseases

This study evaluates the effects of different volumes of aerobic exercise training in cardiovascular parameters of patients with cardiovascular diseases enrolled in a cardiac rehabilitatio...

ARROW:identificAtion of postpRandial biomaRkers tOWards Cardiovascular Prevention

The purpose of this study is to better understand the association between the postprandial biomarker responses after a food challenge with the development of cardiovascular diseases in hea...

Development, Testing, and Validation of A Protocol To Assess Cardiovascular Reactivity in Human Populations

To develop a comprehensive protocol for assessing cardiovascular reactivity to stressors, for use in epidemiological and clinical investigations of cardiovascular diseases in healthy popul...

Cardiovascular Diseases in the Silesian Region in Poland.

The Silesian Cardiovascular Database is an observational study of all patients hospitalized due to cardiovascular diseases. The date include information on the clinical characteristics, tr...

PubMed Articles [11664 Associated PubMed Articles listed on BioPortfolio]

Association between alexithymia and risk of incident cardiovascular diseases in the SUpplémentation en Vitamines et Minéraux AntioXydants (SU.VI.MAX) Cohort.

Although alexithymia has been suggested to be associated with cardiovascular diseases, studies are scarce and a causal relationship is questionable. This study explored the prospective association bet...

12-year trends in cardiovascular risk factors (2002-2005 through 2011-2014) in patients with cardiovascular diseases: Tehran lipid and glucose study.

To examine the trend of cardiovascular diseases (CVD) risk factors among a Middle Eastern population with prevalent CVD during a median follow up of 12 years.

Lipidomic insight into cardiovascular diseases.

Cardiovascular disease is a primary cause of mortality worldwide. Therefore, it is of major interest to identify sensitive molecular markers that predict cardiovascular events and point to therapeutic...

Introduction and Update on Obesity and Cardiovascular Diseases 2018.

Human Emotions on the Onset of Cardiovascular and Small Vessel Related Diseases.

The aim of the present study was to examine the relation between understanding of emotions and cardiovascular related diseases, namely coronary heart disease, diabetes mellitus and obesity. The unique...

Medical and Biotech [MESH] Definitions

Pathological conditions involving the CARDIOVASCULAR SYSTEM including the HEART; the BLOOD VESSELS; or the PERICARDIUM.

Methods and procedures for the diagnosis of diseases or dysfunction of the cardiovascular system or its organs or demonstration of their physiological processes.

Unexpected rapid natural death due to cardiovascular collapse within one hour of initial symptoms. It is usually caused by the worsening of existing heart diseases. The sudden onset of symptoms, such as CHEST PAIN and CARDIAC ARRHYTHMIAS, particularly VENTRICULAR TACHYCARDIA, can lead to the loss of consciousness and cardiac arrest followed by biological death. (from Braunwald's Heart Disease: A Textbook of Cardiovascular Medicine, 7th ed., 2005)

Dental care for patients with chronic diseases. These diseases include chronic cardiovascular, endocrinologic, hematologic, immunologic, neoplastic, and renal diseases. The concept does not include dental care for the mentally or physically disabled which is DENTAL CARE FOR DISABLED.

Blood pressure levels that are between normotension and hypertension. Individuals with prehypertension are at a higher risk for developing cardiovascular diseases. Generally, prehypertension is defined as SYSTOLIC PRESSURE of 131-139 mm Hg and/or DIASTOLIC PRESSURE of 81-89 when the optimal is 120/80 mm Hg. For diabetics and other metabolism diseases the prehypertension is around 110-129/70-79 mm Hg.

More From BioPortfolio on "Mechanisms of Pro-Thrombosis in Diabetes Mellitus -- Ancillary to BARI 2D"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Diabetes
Diabetes is a lifelong condition that causes a person's blood sugar level to become too high. The two main types of diabetes are: type 1 diabetes type 2 diabetes In the UK, diabetes affects approximately 2.9 million people. There are a...

Cardiovascular disease (CVD)
Acute Coronary Syndromes (ACS) Blood Cardiovascular Dialysis Hypertension Stent Stroke Vascular Cardiovascular disease (CVD) includes all the diseases of the heart and circulation including coronary heart disease (angina...

Nephrology - kidney function
Nephrology is a specialty of medicine and pediatrics that concerns itself with the study of normal kidney function, kidney problems, the treatment of kidney problems and renal replacement therapy (dialysis and kidney transplantation). Systemic conditions...


Searches Linking to this Trial