A Phase 4 interventional study of Statin withdrawal in Type 2 Diabetes Mellitus, Atherosclerosis and Dyslipidemia, sponsored by University of Padova. Completed at 1 site in Italy. Open to participants aged 35 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-08-13.
Sponsored by University of Padova · Phase 4, Interventional, and Prevention
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).
1,567 studies on the registry are indexed under Atherosclerosis; 264 are open to participants now.
This study's enrollment of 34 is below the median of 106 across 882 interventional studies indexed under Atherosclerosis.
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Exclusion Criteria:
Patients randomized to this arm will continue their usual statin regimen and dose, without any intervention.
Patients randomized to this arm will stop statin treatment for 5 days.
Other: Statin withdrawal
Patients are instructed to stop taking statin pills for the duration of the study. The rest of therapy will remain unchanged.
Change in EPC levels
Change in EPC levels at day 5 versus baseline will be compared between patients who continued taking statins and patients who withdrawed
Time frame: 5 days
Change in M1/M2 polarization
Change in monocyte macrophage pro- (M1) versus anti- (M2) inflammatory polarization at day 5 versus baseline will be compared between patients who continued taking statins and patients who withdrawed
Time frame: 5 days
Change in hsCRP
Change in high sensitive C-reactive protein levels at day 5 versus baseline will be compared between patients who continued taking statins and patients who withdrawed
Time frame: 5 days
This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
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University of Padova