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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: Completed study, sponsored by US Department of Veterans Affairs.

NCT00252525 is a clinical trial that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 400 participants. According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 400 participants
Start Date 2007-06
Est. Completion 2008-05
US Department of Veterans Affairs

632 total trials

What the finished NCT00252525 record still lists

NCT00252525 is an observational study that tracks outcomes without assigning an intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 0 interventions.

NCT00252525 does not publish any study locations in the registry export this page uses.

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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Source: ClinicalTrials.gov NCT00252525, the US trial registry maintained by the National Library of Medicine. NCT00252525 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.