Non-Traditional Cardiovascular Risk Factors in Type 2 Diabetes Mellitus - Ancillary to VA Study of Glycemic Control

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: NCT00021944
Recruitment Status : Completed
First Posted : August 10, 2001
Last Update Posted : July 29, 2016
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary:
To test whether novel cardiovascular risk factors are related to the presence and development of atherosclerosis and macrovascular events in Type 2 diabetes mellitus and to determine whether intensive glucose lowering therapy will reduce the levels of these cardiovascular risk factors.

Condition or disease
Atherosclerosis Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Non-insulin Dependent Heart Diseases

Detailed Description:


A predominant consequence of Type 2 diabetes mellitus is accelerated development of atherosclerosis related conditions. Conventional cardiovascular risk factors only explain a portion of the excess risk for atherosclerosis in this population. This ancillary study uses the study population and framework of the V A Cooperative study of "Glycemic Control and Complications in DM 2". The Cooperative study is a prospective, two-arm, randomized, controlled, multicenter trial to assess the effects of tight glycemic control, achieved through intensification of treatment, on clinical macrovascular and microvascular complications in patients with Type 2 diabetes mellitus who are in poor glycemic control despite pharmacologic therapy. Cooperative study subjects from multiple sites (340 subjects) are participating in the trial.

The study is in response to an initiative "Ancillary Studies in Heart, Lung, and Blood Disease Trials" released by the National Heart, Lung, and Blood Institute in June 2000.


This ancillary study examines non traditional risk factors which may contribute to accelerated cardiovascular disease in Type 2 diabetes and the effects of intensive versus standard glycemic management on these risk factors. Specific short-term primary aims include determining the cross-sectional relationship between baseline levels and the presence of atherosclerosis as measured by electron beam computed tomography assessment of coronary artery (CAC) and abdominal aortic calcium (AAC) and the prevalence of clinical macrovascular disease. An estimated 340 Cooperative study subjects from multiple sites will be asked to participate in this additional study. At their baseline visit, subjects will have additional blood and urine collected for a) VLDL, IDL and LDL subfractions b) measures of in vivo oxidative stress (oxidized-phospholipids on plasma LDL, autoantibodies to epitopes of oxidized LDL, F2-isoprostane levels) c) AGE-LDL levels, and d) markers of endothelial activation/injury (PAI-1, VCAM-1 and ICAM-1) and inflammation (C-reactive protein and fibrinogen). Subjects will also have CAC and AAC determined. After enrollment in the study, participants will have measurements of cardiovascular risk factors repeated at six months. Primary and secondary macrovascular endpoints will be identical to those defined in the VA Cooperative study (Primary: myocardial infarction, cardiovascular death, stroke, congestive heart failure, invasive vascular therapy (coronary or peripheral), and amputation due to ischemic gangrene; Secondary: angina pectoris, transient ischemic attacks, and peripheral artery disease). Statistical methods, depending on the specific aim will include categorical age and sex adjusted analyses, t-tests, and multiple regression models. Long-term aims will include evaluating the prospective relationship of these novel cardiovascular risk factors to the progression of atherosclerosis and the development of macrovascular disease in this same population.

Study Type : Observational
Time Perspective: Retrospective
Study Start Date : April 2001
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005

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U.S. FDA Resources

Information from the National Library of Medicine

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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): NCT00021944

Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
OverallOfficial: Peter Reaven Carl T. Hayden Veteran Affairs Medical Center

Publications: Identifier: NCT00021944     History of Changes
Other Study ID Numbers: 977
R01HL067690 ( U.S. NIH Grant/Contract )
First Posted: August 10, 2001    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: January 2008

Additional relevant MeSH terms:
Diabetes Mellitus
Cardiovascular Diseases
Heart Diseases
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Arterial Occlusive Diseases
Vascular Diseases