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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: Completed Phase 2 study of Type 1 Diabetes, sponsored by University of California, Davis.
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 766-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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
Interventions
- DRUG Simvastatin
Study Locations (1)
California
- UCDavis Medical Center - Sacramento
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2002-10 |
| Est. Completion | 2005-07 |
| Phase | Phase 2 |
What the finished NCT00441844 record still lists
NCT00441844 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 766-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (93% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00441844's enrollment target sits among peer trials
50 87th of 198 higher than 107 of 198 other Type 1 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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