Independent directory Public ClinicalTrials.gov records United States
ClinicalTrials.gov record
Completed No phase listed Observational

Markers and Mechanisms of Vascular Disease in Type II Diabetes

ClinicalTrials.gov ID: NCT00256646

Public ClinicalTrials.gov record NCT00256646. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 15, 2026, 1:52 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

CSP #465D - Markers And Mechanisms of Vascular Disease in Type II Diabetes

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00256646
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Enrollment
298 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
40 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 31, 2007
Primary completion
Apr 30, 2008
Completion
Apr 30, 2008
Last update posted
May 22, 2014

2007 – 2008

United States locations

U.S. sites
16
U.S. states
12
U.S. cities
16
Facility City State ZIP Site status
Carl T. Hayden VA Medical Center Phoenix Arizona 85012
Southern Arizona VA Health Care System, Tucson Tucson Arizona 85723
VA Central California Health Care System, Fresno Fresno California 93703
VA Medical Center, Long Beach Long Beach California 90822
VA San Diego Healthcare System, San Diego San Diego California 92161
Miami VA Healthcare System, Miami, FL Miami Florida 33125
Edward Hines, Jr. VA Hospital Hines Illinois 60141-5000
Richard Roudebush VA Medical Center, Indianapolis Indianapolis Indiana 46202-2884
VA Medical Center, Lexington Lexington Kentucky 40502
VA Medical Center, Minneapolis Minneapolis Minnesota 55417
VA Medical Center, Omaha Omaha Nebraska 68105-1873
VA New Jersey Health Care System, East Orange East Orange New Jersey 07018
VA Pittsburgh Health Care System Pittsburgh Pennsylvania 15240
Michael E. DeBakey VA Medical Center (152) Houston Texas 77030
VA South Texas Health Care System, San Antonio San Antonio Texas 78229
VA Medical Center, Salem VA Salem Virginia 24153

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00256646, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 22, 2014 · Synced Sep 15, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00256646 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →