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

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00021944
First received: August 10, 2001
Last updated: January 18, 2008
Last verified: January 2008
  Purpose

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
Atherosclerosis
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Non-Insulin Dependent
Heart Diseases

Study Type: Observational
Study Design: Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: April 2001
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Detailed Description:

BACKGROUND:

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.

DESIGN NARRATIVE:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00021944

Sponsors and Collaborators
Investigators
Investigator: Peter Reaven Carl T. Hayden Veteran Affairs Medical Center
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00021944     History of Changes
Other Study ID Numbers: 977
Study First Received: August 10, 2001
Last Updated: January 18, 2008
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on October 20, 2014