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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Gladys Velarde, University of Rochester
ClinicalTrials.gov Identifier:
NCT01785615
First received: February 1, 2013
Last updated: February 7, 2013
Last verified: February 2013
  Purpose

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.

Condition Intervention Phase
Metabolic Syndrome
Drug: Atorvastatin
Other: Placebo
Phase 1
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 88
Study Start Date: November 2004
Estimated Study Completion Date: April 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atorvastatin
44 women randomized to 80 mg atorvastatin for 6weeks
Drug: Atorvastatin
80mg
Other Name: Lipitor
Placebo Comparator: sugar pill
44 women randomized to placebo for 6 weeks
Other: Placebo
80mg

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01785615

Locations
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Pfizer
Investigators
Principal Investigator: Gladys P Velarde, MD University of Rochester
  More Information

No publications provided

Responsible Party: Gladys Velarde, Principle Investigator, University of Rochester
ClinicalTrials.gov Identifier: NCT01785615     History of Changes
Other Study ID Numbers: Protocol No. 1988, Grant# 2004-1035
Study First Received: February 1, 2013
Last Updated: February 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Rochester:
metabolic syndrome
atorvastatin
women

Additional relevant MeSH terms:
Metabolic Syndrome X
Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Disease
Pathologic Processes
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 19, 2014