Markers and Mechanisms of Vascular Disease in Type II Diabetes
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.
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
Conditions
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
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00256646 live on ClinicalTrials.gov.