Overview

Monocyte Function and Inflammation in Type 1 Diabetes and Its Modulation

Status:
Completed
Trial end date:
2005-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of California, Davis
Collaborators:
Juvenile Diabetes Research Foundation
National Institutes of Health (NIH)
Treatments:
Simvastatin
Criteria
Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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