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NCT00441844 · ClinicalTrials.gov registry record · Phase 2

Monocyte Function and Inflammation in Type 1 Diabetes and Its Modulation

A Phase 2 study of Type 1 Diabetes, sponsored by University of California, Davis.

Completed
Registry status
Phase 2
Development phase
50
Enrollment target
1
Study location

NCT00441844 is a Phase 2 study of Type 1 Diabetes that has completed, run by University of California, Davis. The registered enrollment target is 50 participants, below the 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00441844, a Phase 2 study of Type 1 Diabetes, has completed, sponsored by University of California, Davis.

COMPLETED
Registry status
Phase 2
Development phase
50 participants
Enrollment target
1
Study location

Study Summary

Type I diabetes (T1DM) is associated with an increased risk of vascular complications. While the precise mechanism(s) by which diabetes accelerates atherosclerosis has not been elucidated, several lines of evidence point to the role of increased inflammation in the pathogenesis of these vasculopathies. The monocyte-macrophage is a pivotal cell in atherogenesis and is readily accessible for study. However, there is scanty data on monocyte function and inflammation in T1DM. Simvastatin, a HMG-CoA reductase inhibitor, has recently been shown to reduce cardiovascular events in diabetic patients (T1DM and T2DM in the Heart Protection Study). Recent studies demonstrate that simvastatin decreased C-reactive protein and decreased pro-atherogenic activity of monocytes in non-diabetic subjects. However, there is a paucity of data on the effect of simvastatin on inflammation and monocyte function in Type 1 diabetes. Thus, the purpose of this study is Aim 1) to assess biomarkers of inflammation in T1DM compared to matched controls (n=50/group). Aim 2) Also, we will assess the effect of simvastatin (20mg/day) therapy on inflammation and monocyte function in T1DM in a randomized, placebo-controlled, double blind trial.

Conditions Studied

Type 1 Diabetes

Interventions

  • DRUG Simvastatin

Study Locations (1)

California

  • UCDavis Medical Center - Sacramento

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2002-10
Est. Completion 2005-07
Phase Phase 2

Sponsor

University of California, Davis

657 total trials

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What the Registry Record Tells You About NCT00441844

The ClinicalTrials.gov registry entry for NCT00441844 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (94% lower). The listed sponsor is University of California, Davis, which has 657 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Type 1 Diabetes appearing as the primary indexed condition, and to 1 intervention - of which Simvastatin is the first listed.

NCT00441844 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT00441844 about?

NCT00441844 is a clinical study titled "Monocyte Function and Inflammation in Type 1 Diabetes and Its Modulation". Type I diabetes (T1DM) is associated with an increased risk of vascular complications. While the precise mechanism(s) by which diabetes accelerates atherosclerosis has not been elucidated, several lines of evidence point to the role of increased inflammation in the pathogenesis of these vasculopathi...

What is the current status of trial NCT00441844?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2002-10. Estimated completion is 2005-07.

What conditions does trial NCT00441844 study?

This clinical trial studies the following conditions: Type 1 Diabetes.

What interventions are being tested in trial NCT00441844?

The interventions under investigation include: Simvastatin (DRUG).

Who is sponsoring clinical trial NCT00441844?

This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00441844 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.