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NCT00252525 · ClinicalTrials.gov registry record
Correlation of Plasma Endothelial Cell Activity With Cardiovascular Events in Patients With Diabetes Mellitus Type 2
A clinical trial, sponsored by US Department of Veterans Affairs.
- Completed
- Registry status
- 400
- Enrollment target
NCT00252525 is a clinical trial that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 400 participants.
The verdict
NCT00252525 has completed, sponsored by US Department of Veterans Affairs.
- COMPLETED
- Registry status
- 400 participants
- Enrollment target
Study Summary
CSP 465-B, Correlation of Plasma Endothelial Cell (Basic Fibroblast Growth Factor) Activity With Cardiovascular Events in Patients with Diabetes Mellitus, Type II. Mark Zimering M.D. Objectives: Endothelial cell dysfunction plays a role in the development of the atherosclerotic vascular lesion and it is also thought to provide a mechanism for increased urinary albumin excretion in type 2 diabetes mellitus. Micro- or macroalbuminuria are associated with increased cardiovascular (CV) morbidity and mortality in type 2 diabetes mellitus. In at least one longitudinal study in older-age onset patients, micro-or macroalbuminuria robustly predicted increased CV risk independent of other diabetes-related factors.1 The pathogenetic mechanisms underlying a significant association between micro- or macroalbuminuria and CV risk in diabetes mellitus are not known but may include: growth factors, clotting factors, lipids, or hemodynamic factors. The aim of the present study is to investigate whether an angiogenic growth factor, basic fibroblast growth factor (bFGF), plays a role in increased CV risk in type 2 diabetes mellitus. Research Plan: BFGF (FGF-2) is one of the most potent known angiogenesis factors. Increased bFGF was previously associated with both endothelial cell injury and micro- or macroalbuminuria. In a prior study of 73 older-age onset veterans with type 2 diabetes mellitus (JCEM, 1996), we found plasma endothelial cell (bFGF) activity was significantly associated with glycemic levels, and (in multiple regression analysis) independently associated with both microalbuminuria and retinopathy. We will test whether plasma endothelial cell (bFGF) activity is significantly, independently associated with a pooled endpoint of cardiovascular events that includes myocardial infarction (MI), coronary revascularization, congestive heart failure (CHF), or CV mortality. We expect that increased bFGF may itself be a robust marker for increased CV risk in diabetes mellitus for t
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 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 NCT00252525
The ClinicalTrials.gov registry entry for NCT00252525 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 400 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 0 interventions.
NCT00252525 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00252525 about?
NCT00252525 is a clinical study titled "Correlation of Plasma Endothelial Cell Activity With Cardiovascular Events in Patients With Diabetes Mellitus Type 2". CSP 465-B, Correlation of Plasma Endothelial Cell (Basic Fibroblast Growth Factor) Activity With Cardiovascular Events in Patients with Diabetes Mellitus, Type II. Mark Zimering M.D. Objectives: Endothelial cell dysfunction plays a role in the development of the atherosclerotic vascular lesion and...
What is the current status of trial NCT00252525?
This trial is currently completed. The enrollment target is 400 participants. The study started on 2007-06. Estimated completion is 2008-05.
Who is sponsoring clinical trial NCT00252525?
This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.
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