Monocyte Function and Inflammation in Type 1 Diabetes and Its Modulation
Phase 2 Study Examining the Effect of Simvastatin vs Placebo on Monocyte Function and Inflammation in Patients With Type 1 Diabetes
2 other identifiers
interventional
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2002
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 27, 2007
CompletedFirst Posted
Study publicly available on registry
March 1, 2007
CompletedMarch 1, 2007
February 1, 2007
February 27, 2007
February 28, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
HsCRP
Monocyte function
Secondary Outcomes (1)
Plasma biomarkers
Interventions
Eligibility Criteria
You may qualify if:
- Type I diabetic patients (onset \< 20years and on insulin therapy since diagnosis) without clinical macrovascular complications, present age \> 20 years with duration of diabetes \> 1yr.
You may not qualify if:
- HbA1c over the last year \>10%
- Patients on glucophage and/or the thiazolidenediones will be excluded, since these drugs appear to be anti-inflammatory.
- Theumatoid arthritis;
- Abnormal liver function,
- Hypo- or hyperthyroidism;
- Malabsorption;
- Steroid therapy,
- Anti-inflammatory drugs except aspirin (81mg/day)
- Pregnancy,
- Lactation,
- Smoking,
- Abnormal complete blood count; and
- Alcohol consumption \> 1 oz/day
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, Davislead
- Juvenile Diabetes Research Foundationcollaborator
- National Institutes of Health (NIH)collaborator
Study Sites (1)
UCDavis Medical Center
Sacramento, California, 95817, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ishwarlal Jialal', MD, PhD
UCDavis Professor
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 27, 2007
First Posted
March 1, 2007
Study Start
October 1, 2002
Study Completion
July 1, 2005
Last Updated
March 1, 2007
Record last verified: 2007-02