Monocyte Function and Inflammation in Type 1 Diabetes and Its Modulation

Completed · Phase 2

Conditions studied: Type 1 Diabetes

In brief

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.

Key facts

Study ID

NCT00441844

Run by

University of California, Davis

People needed

50

Starts

2002-10-01

Expected to finish

2005-07-01

Last updated by the study team

2007-03-01

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• UCDavis Medical Center — Sacramento, California, United States

Full record on ClinicalTrials.gov

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