Prothrombotic Inflammatory Markers in Women With Metabolic Syndrome - Effect of Atorvastatin (PINK)
Recruitment status was Active, not recruiting
Little is known regarding the association of individual components of the metabolic syndrome (MBS) and prothrombotic, inflammatory and preclinical cardiac structural and functional markers in women with this syndrome. Less is known about adequate treatment as the pathological mechanism of this syndrome is not well understood.
The purpose of this study is two fold;
- To determine basic differences in biochemical and cardiovascular structural markers in women with and those without MBS and their association with the individual components of MBS.
- To determine the impact of atorvastatin to lower the risk factors of Metabolic Syndrome. Atorvastatin is one of the most effective drugs approved by the United States Food and Drug Administration (FDA) for the treatment of high cholesterol. It belongs to a class of drugs called statins and its role in primary prevention is still unclear. Thus this population seems to be an ideal group that may benefit from this intervention.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Interactions of Thrombogenic, Lipogenic, and Inflammatory Markers in Women With the Metabolic Syndrome - Effect of Atorvastatin|
- Basic differences in cardio-metabolic markers in women with vs. those without the metabolic syndrome and impact of atorvastatin on these markers. [ Time Frame: three weeks - from start of treatment ] [ Designated as safety issue: No ]We sought to determine basic differences and frequency of cardiometabolic biological markers such as inflammatory (hsCR), prothrombotic (PAI-I), lipogenic (HDL, Triglycerides, Apolipoprotein-A, Apolipoprotein-B and leptin), oxidative stress (myeloperoxidase), platelet reactivity (ADP and Collagen assays) and structural markers such as Carotid Intima Media Thickening (C-IMT) and simple echo markers (Left ventricular (LV) wall thickness of inter-ventricular septum (IVS), posterior wall (PW), LV mass, left atrial size and fractional shortening) in women with vs. those without the Metabolic Syndrome. The impact of high dose atorvastatin vs. Placebo on these biological markers at 3 weeks, 6 weeks and 12 weeks after randomization was also studied.
|Study Start Date:||November 2004|
|Estimated Study Completion Date:||April 2013|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
44 women randomized to 80 mg atorvastatin for 6weeks
Other Name: Lipitor
Placebo Comparator: sugar pill
44 women randomized to placebo for 6 weeks
The first phase of the study is an observational phase as previously described. The second phase was a prospective evaluation of the effect of a well known "statin" drug (Liptor) on different biochemical factors measured in the blood. The eligible study participants had blood work done upon enrollment and if criteria was met(according to the Adult Treatment Panel III), they were given dietary counseling (NYHA - New York Heart Association Step 1 diet) as a lead in phase. Lab work was repeated at 3 weeks to evaluate the impact of the diet and if participant's profile still met criteria for MBS,randomization for either atorvastatin (Liptor) 80mg or placebo (sugar pill) for 12 weeks took place.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01785615
|United States, New York|
|University of Rochester Medical Center|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Gladys P Velarde, MD||University of Rochester|