Type 1 Diabetes Clinical Trial
Official title:
Phase 2 Study Examining the Effect of Simvastatin vs Placebo on Monocyte Function and Inflammation in Patients With Type 1 Diabetes
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.
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.
At baseline and post-therapy, fasting blood will be obtained for routine laboratories
(including lipid profile, glucose, glycated hemoglobin), free fatty acid levels, biomarkers
of inflammation [high sensitive C-reactive protein, plasma soluble cell adhesion molecules
(sVCAM,sICAM, sE-selectin and sP-selectin) , CD40 ligand, monocyte pro-atherogenic activity
(superoxide anion, monocyte chemotactic protein-1, interleukin (IL)-1b, IL-6 and tumor
necrosis factor-a release, adhesion to human aortic endothelium, CD40 expression)] etc., and
24-hour urine for microalbumin
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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