Prothrombotic Inflammatory Markers in Women With Metabolic Syndrome - Effect of Atorvastatin

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

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;

1. 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.

2. 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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Rochester
• Collaborator: Pfizer
• Treatments: Atorvastatin; Atorvastatin Calcium

Criteria

Inclusion Criteria:

• Women between the ages of 18-75 with Metabolic syndrome

• Abdominal circumference > 35 in

• Hypertriglyceridemia > 150mg/dl

• HDL <50

• Blood Pressure >130/85

• Fasting Glucose >100

Exclusion Criteria:

• Pregnant or planning to become pregnant in the next 6-12 months

• Receiving lipid-lowing drugs

• Obstructive hepatobiliary disease or serious hepatic disease

• Diabetes, cardiovascular disease (CVD), hypothyroidism, active infection, cancer, recent surgery

• Fulfill criteria to receive statin based on LDL levels, risk factors, and Framingham risk scoring outlined on ATP111/NCEP 111 recommendations

• Documented allergic reaction to statin in past

• unexplained elevation in creatinine kinase levels > 3 times upper limit