The VA HDL Intervention trial (VA-HIT) was a multicenter, placebo controlled, randomized trial that showed that gemfibrozil significantly reduced major cardiovascular events in 2531 men with coronary heart disease, low levels of low density lipoprotein (LDL) cholesterol and low levels of high density lipoprotein (HDL) cholesterol. In addition to its unique lipid profile, the VA-HIT population also had a high prevalence of diabetes, impaired fasting glucose, or high fasting plasma insulin; central obesity; and hypertension, which are all components (together with high triglycerides and low ILL-cholesterol) of a constellation of risk factors known as the metabolic syndrome. Since prior clinical trials have not enrolled this type of population, the VA- HIT database is a unique resource. The purpose of the present proposal is to use this database to study additional risk markers that were measured in the study population. Specific proposed analyses are: 1. An analysis of the association between levels of glucose tolerance, insulin resistance and other features of the metabolic syndrome, occurrence of major cardiovascular outcomes, and gemfibrozil efficacy. 2. An analysis of the effect of gemfibrozil on progression of carotid atherosclerosis, as measured by B-mode ultrasound. 3. An analysis of the association between LDL particle size distribution and lipoprotein subclass distribution; homocysteine; lipoprotein(a); C- reactive protein, tissue plasminogen activator; fibrinogen; and factor VII; major cardiovascular outcomes, and gemfibrozil efficacy. Written documentation that the data will be available to us is included in the letter from Dr. Peter Peduzzi of the VA Cooperative Studies Program.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Small Research Grants (R03)
Project #
1R03HL069111-01
Application #
6434767
Study Section
Clinical Trials Review Committee (CLTR)
Program Officer
Cooper, Lawton S
Project Start
2001-09-30
Project End
2003-08-31
Budget Start
2001-09-30
Budget End
2002-08-31
Support Year
1
Fiscal Year
2001
Total Cost
$57,930
Indirect Cost
Name
University of Minnesota Twin Cities
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
168559177
City
Minneapolis
State
MN
Country
United States
Zip Code
55455