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NCT00256646 · ClinicalTrials.gov registry record
Markers and Mechanisms of Vascular Disease in Type II Diabetes
A clinical trial, sponsored by US Department of Veterans Affairs.
- Completed
- Registry status
- 298
- Enrollment target
NCT00256646 is a clinical trial that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 298 participants.
The verdict
NCT00256646 has completed, sponsored by US Department of Veterans Affairs.
- COMPLETED
- Registry status
- 298 participants
- Enrollment target
Study Summary
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 interes
Interventions
- DRUG Rosiglitazone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 298 participants |
| Start Date | 2007-06 |
| Est. Completion | 2008-05 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00256646
The ClinicalTrials.gov registry entry for NCT00256646 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 298 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is US Department of Veterans Affairs, which has 632 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Rosiglitazone is the first listed.
NCT00256646 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00256646 about?
NCT00256646 is a clinical study titled "Markers and Mechanisms of Vascular Disease in Type II Diabetes". 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 i...
What is the current status of trial NCT00256646?
This trial is currently completed. The enrollment target is 298 participants. The study started on 2007-06. Estimated completion is 2008-05.
What interventions are being tested in trial NCT00256646?
The interventions under investigation include: Rosiglitazone (DRUG).
Who is sponsoring clinical trial NCT00256646?
This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.
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