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

University of Rochester

Status and phase

Completed

Phase 2

Phase 1

Conditions

Metabolic Syndrome

Treatments

Drug: Atorvastatin

Other: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01785615

Grant# 2004-1035 (Other Grant/Funding Number)

Protocol No. 1988

Details and patient eligibility

About

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.

Full description

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 (Lipitor) 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 (Lipitor) 80mg or placebo (sugar pill) for 12 weeks took place.

Enrollment

116 patients

Sex

Female

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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