SStatin-EPC
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
Sponsor study identifier
interventional
34
1 country
1
Study Start
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2013
Actual (reported)Study Completion
August 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2013
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
May 15, 2012
Actual (reported)May 17, 2012
Actual (reported)August 2013
Actual (reported)August 2013
Actual (reported)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
5 days
Change in M1/M2 polarization
5 days
Change in hsCRP
5 days
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.
Patients are instructed to stop taking statin pills for the duration of the study. The rest of therapy will remain unchanged.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University Hospital Diabetes Outpatient Clinic
Padova, 35100, Italy
Gian Paolo Fadini, M.D.
University of Padova
34 participants (actual enrollment reported by the registry).
First Submitted
May 15, 2012
First Posted
May 17, 2012
Study Start
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
August 2013
Actual (reported)Study Completion
August 2013
Actual (reported)Last Updated
August 13, 2013
Record last verified: 2013-08
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Source: ClinicalTrials.gov.
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