Markers and Mechanisms of Vascular Disease in Type II Diabetes

This study has been completed.
Sponsor:
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00256646
First received: November 17, 2005
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

OBJECTIVES: Vascular Disease is the leading cause of complications and death in patients with diabetes. Risk markers and underlying mechanisms have not been fully elucidated, and may differ from those in non-diabetic individuals. The unifying theme for the Program Project is that hyperglycemia and insulin resistance alter a number of biological processes which interact in vicious cycles to accelerate atherogenesis and are consequently major underlying risk factors for vascular disease. The overall objectives are to define these unique processes and to elucidate underlying biochemical, metabolic, and genetic determinants of vascular disease complications in diabetes.

RESEARCH PLAN: Over the past 4 years, we have collaborated with the DCCT/EDIC Study Group, and have made novel observations regarding vascular disease pathogenesis in Type 1 Diabetes. This work has focused our studies on specific pathogenic processes. We will now study a Type 2 Diabetes cohort from the VA Cooperative Study, "Glycemic Control and the Complications of Diabetes, Type 2", with high vascular disease event rates. These collaborations provide a unique opportunity to address the pathogenesis of accelerated atherogenesis in the two main types of diabetes, and will greatly augment the scientific knowledge that will be gained in the conduct of these world-class prospective trials.

METHODS: The Program Project has 4 projects and 3 cores. Project 1 will assess lipoproteins, glycoxidative stress, and inflammation as risk factors in studies involving Type 2 Diabetes patients and cultured cell systems. Based on preliminary data from our initial studies Type 1 patients, changes in the NMR lipoprotein subclass profile will be emphasized.

Project 2 will elucidate interactions between inflammation, modifications of lipoproteins, and autoimmunity in vascular disease risk. These novel concepts are also based upon exciting preliminary data pertaining to LDL-antibody complexes.

Project 3 will pursue interesting preliminary data and define the role of the kallikrein-kinin system in vascular disease complications, with effects on mitogenesis and matrix production.

Project 4 will assess the role of the Insulin Resistance Syndrome and novel factors secreted from adipocytes in the pathophysiology of biochemical risk factors and cardiovascular complications.

Cores include an Administrative Core, a Biostatistics and Epidemiology Core which will link with the trials data coordinating centers, and Molecular and Statistical Genetics Core. Investigators will work in close collaboration with the VA Executive Committee, Study Centers, the Hines Coordinating Center, and some of the other ancillary studies. All data analysis involving clinical outcomes will be performed at the Hines Coordinating Center.

There is true synergism among the projects at both scientific and logistical levels. The Program Project design allows for interactions among multidisciplinary investigators studying the same cohort, which will define how multiple pathological processes interact at the level of the arterial wall to promote atherosclerosis.


Condition Intervention
Type 2 Diabetes Mellitus
Drug: Rosiglitazone

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: CSP #465D - Markers And Mechanisms of Vascular Disease in Type II Diabetes

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • The primary outcome measure is to define these unique processes and to elucidate underlying biochemical, metabolic, and genetic determinants of vascular disease complications in diabetes. [ Time Frame: 2, 4, and 6 years. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

samples without DNA


Enrollment: 298
Study Start Date: June 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
Patients who are enrolled in the ongoing randomized clinical trial AGlycemic Control and Complications in Diabetes Mellitus Type 2".
Drug: Rosiglitazone
ROSIGLITAZONE (roe si GLI ta zone) helps to treat type 2 diabetes. It helps to control blood sugar. Treatment is combined with diet and exercise.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who are enrolled in the ongoing randomized clinical trial AGlycemic Control and Complications in Diabetes Mellitus Type 2".

Criteria

Inclusion Criteria:

Patients with type 2 DM who are no longer responsive to maximum dose of one or more oral agents

Exclusion Criteria:

Patients that did not participate in the VADT.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256646

Locations
United States, Arizona
Carl T. Hayden VA Medical Center
Phoenix, Arizona, United States, 85012
Southern Arizona VA Health Care System, Tucson
Tucson, Arizona, United States, 85723
United States, California
VA Central California Health Care System, Fresno
Fresno, California, United States, 93703
VA Medical Center, Long Beach
Long Beach, California, United States, 90822
VA San Diego Healthcare System, San Diego
San Diego, California, United States, 92161
United States, Florida
Miami VA Healthcare System, Miami, FL
Miami, Florida, United States, 33125
United States, Illinois
Edward Hines, Jr. VA Hospital
Hines, Illinois, United States, 60141-5000
United States, Indiana
Richard Roudebush VA Medical Center, Indianapolis
Indianapolis, Indiana, United States, 46202-2884
United States, Kentucky
VA Medical Center, Lexington
Lexington, Kentucky, United States, 40502
United States, Minnesota
VA Medical Center, Minneapolis
Minneapolis, Minnesota, United States, 55417
United States, Nebraska
VA Medical Center, Omaha
Omaha, Nebraska, United States, 68105-1873
United States, New Jersey
VA New Jersey Health Care System, East Orange
East Orange, New Jersey, United States, 07018
United States, Pennsylvania
VA Pittsburgh Health Care System
Pittsburgh, Pennsylvania, United States, 15240
United States, Texas
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, United States, 77030
VA South Texas Health Care System, San Antonio
San Antonio, Texas, United States, 78229
United States, Virginia
VA Medical Center, Salem VA
Salem, Virginia, United States, 24153
Puerto Rico
VA Medical Center, San Juan
San Juan, Puerto Rico, 00921
Sponsors and Collaborators
American Diabetes Association
Investigators
Study Chair: Carlos Abraira, MD Miami VA Healthcare System, Miami, FL
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00256646     History of Changes
Other Study ID Numbers: 465D
Study First Received: November 17, 2005
Last Updated: May 21, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cardiovascular Diseases
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014