Type 2 Diabetes Mellitus Clinical Trial
Official title:
Evaluation of the Effects of 5-day Statin Withdrawal on Endothelial Progenitor Cells and Inflammatory Markers in Type 2 Diabetic Patients. A Controlled Randomized Study
Statins are commonly prescribed to lower cardiovascular risk in primary and secondary
prevention. Despite their well known efficacy, statin withdrawal is a common event. Even a
short term statin withdrawal can have dramatic consequences on atherosclerotic plaque
stability, owing to a rebound in cholesterol levels and inflammation.
The effects of a short term statin withdrawal on endothelial progenitor cells (EPC) and
monocyte/macrophage polarization is unknown.
In this study, the investigators will explore the effects of a 5-day statin withdrawal on
EPC and monocyte/macrophage polarization, together with other inflammatory biomarkers in
type 2 diabetic patients. The investigators hypothesize that statin withdrawal determines a
reduction in EPC levels and an inflammatory cell polarization.
Patients will be randomized to continue their habitual statin regimen or to withdraw statin.
At baseline and 5 days later, blood samples will be collected for experimental measures.
Statins are commonly prescribed to lower cardiovascular risk in primary and secondary
prevention. Despite their well known efficacy with relatively low NNTs, statin withdrawal is
a common event for several reasons. Patients often stop statin therapies for long or short
periods of time. Even a short term statin withdrawal can have dramatic consequences on
atherosclerotic plaque stability, owing to a rebound in cholesterol levels and inflammation.
Previous studies have demonstrated worsening of inflammation and endothelial function after
a short-term statin withdrawal. This may be even more dramatic in patients who are at
increased risk of cardiovascular disease, such as diabetic patients.
Endothelial integrity is accomplished through the contribution of circulating endothelial
progenitor cells (EPC) which repair the damaged endothelial layer and contribute to
cardiovascular health in general. EPC are stimulated by statins, but there is no data on the
effect of statin withdrawal on EPCs.
One important aspect of inflammation is the pro- versus anti-inflammatory polarization of
circulating monocyte/macrophage (MM) cells. Schematically, MM can exist in 2 different
states of activation: the classically activated pro-inflammatory cells (M1) and the
alternatively activated anti-inflammatory cells (M2). The balance between these 2 (M1/M2
ratio) reflects the state of MM polarization. The effects of statin withdrawal on MM
polarization is unknown.
In this study, we will explore the effects of a 5-day statin withdrawal on EPC and
monocyte/macrophage polarization, together with other inflammatory biomarkers (namely high
sensitive C-reactive protein) in type 2 diabetic patients. We hypothesise that statin
withdrawal determines a reduction in EPC levels and an inflammatory cell polarization.
Patients will be randomized to continue their habitual statin regimen or to withdraw statin.
At baseline and 5 days later, blood samples will be collected for experimental measures
(EPC, M1, M2 and hsCRP).
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Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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