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

Metabolic Syndrome Clinical Trial

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Official title:

Interactions of Thrombogenic, Lipogenic, and Inflammatory Markers in Women With the Metabolic Syndrome - Effect of Atorvastatin

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01785615
• Other study ID #: Protocol No. 1988
• Secondary ID: Grant# 2004-1035
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: February 1, 2013
• Last updated: February 7, 2013
• Start date: November 2004
• Est. completion date: April 2013

Study information

• Verified date: February 2013
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 88
• Est. completion date: April 2013
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Drug:
• Atorvastatin
80mg

Other:
• Placebo
80mg

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Basic differences in cardio-metabolic markers in women with vs. those without the metabolic syndrome and impact of atorvastatin on these markers.	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.	three weeks - from start of treatment	No