Overview

This trial is active, not recruiting.

Condition metabolic syndrome
Treatments atorvastatin, placebo
Phase phase 1/phase 2
Sponsor University of Rochester
Collaborator Pfizer
Start date November 2004
End date December 2011
Trial size 88 participants
Trial identifier NCT01785615, Grant# 2004-1035, Protocol No. 1988

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
44 women randomized to 80 mg atorvastatin for 6weeks
atorvastatin Lipitor
80mg
(Placebo Comparator)
44 women randomized to placebo for 6 weeks
placebo
80mg

Primary Outcomes

Measure
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

Eligibility Criteria

Female participants from 18 years up to 75 years old.

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

Additional Information

Official title Interactions of Thrombogenic, Lipogenic, and Inflammatory Markers in Women With the Metabolic Syndrome - Effect of Atorvastatin
Principal investigator Gladys P Velarde, MD
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 (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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2013.
Information provided to ClinicalTrials.gov by University of Rochester.