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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01785615
First Posted: February 7, 2013
Last Update Posted: June 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by (Responsible Party):
Gladys Velarde, University of Rochester
February 1, 2013
February 7, 2013
September 3, 2013
June 7, 2017
June 7, 2017
November 2004
December 2011   (Final data collection date for primary outcome measure)
  • Mean Low Density Lipoprotein Cholesterol in Blood [ Time Frame: 6 weeks ]
    Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.
  • Mean Triglycerides in Blood [ Time Frame: 6 weeks ]
    Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.
  • Mean Apolipoprotein B in Blood [ Time Frame: 6 weeks ]
    Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.
  • Mean Apolipoprotein B/ Apolipoprotein A1 Ratio in Blood [ Time Frame: 6 weeks ]
    Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing. The ratio of Apo B to Apo A1 ratio was calculated.
  • Mean High Sensitivity C-reactive Protein in Blood [ Time Frame: 6 weeks ]
    Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing. The ratio of Apo B to Apo A1 ratio was calculated
  • Mean Waist Circumference [ Time Frame: 6 weeks ]
    Waist circumference was measured with a ruler tape.
  • Mean Systolic Blood Pressure [ Time Frame: 6 weeks ]
    Measured with a blood pressure cuff
  • Mean Diastolic Blood Pressure [ Time Frame: 6 weeks ]
    Measured with a blood pressure cuff
  • Mean High Density Lipoprotein Cholesterol in Blood [ Time Frame: 6 weeks ]
    Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.
  • Mean Fasting Plasma Glucose in Blood [ Time Frame: 6 weeks ]
    Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.
  • Mean Aspartate Aminotransferase in Blood [ Time Frame: 6 weeks ]
    Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.
  • Mean Alanine Aminotransferase in Blood [ Time Frame: 6 weeks ]
    Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.
  • Mean Leptin in Blood [ Time Frame: 6 weeks ]
    Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.
  • Mean Soluble Intercellular Adhesion Molecule in Blood [ Time Frame: 6 weeks ]
    Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.
  • Mean Soluble Vascular Adhesion Molecule in Blood [ Time Frame: 6 weeks ]
    Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.
  • Mean Plasminogen Activator Inhibitor-1 in Blood [ Time Frame: 6 weeks ]
    Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.
  • Mean Myeloperoxidase in Blood [ Time Frame: 6 weeks ]
    Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.
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 ]
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.
Complete list of historical versions of study NCT01785615 on ClinicalTrials.gov Archive Site
  • Mean Waist Circumference [ Time Frame: week 0 ]
    Waist circumference was measured with a ruler tape.
  • Mean Low Density Lipoprotein Cholesterol in Blood [ Time Frame: 0 weeks ]
    Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.
  • Mean Triglycerides in Blood [ Time Frame: 0 weeks ]
    Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.
  • Mean Myeloperoxidase in Blood [ Time Frame: 0 weeks ]
    Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.
  • Mean Fasting Blood Glucose in Blood [ Time Frame: 0 weeks ]
    Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.
  • Mean High Density Lipoprotein Cholesterol in Blood [ Time Frame: 0 weeks ]
    Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.
  • Mean Intercellular Adhesion Molecule in Blood [ Time Frame: 0 weeks ]
    Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.
  • Mean Systolic Blood Pressure [ Time Frame: 0 weeks ]
    Measured with a blood pressure cuff
  • Mean Diastolic Blood Pressure [ Time Frame: 0 weeks ]
    Measured with a blood pressure cuff
  • Mean Vascular Adhesion Molecule in Blood [ Time Frame: 0 weeks ]
    Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.
  • Mean Apolipoprotein A-1 in Blood [ Time Frame: 0 weeks ]
    Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.
  • Mean Apolipoprotein B in Blood [ Time Frame: 0 weeks ]
    Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.
  • Mean Apolipoprotein B/ Apolipoprotein A1 Ratio in Blood [ Time Frame: 0 weeks ]
    Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing. The ratio of Apo B to Apo A1 ratio was calculated.
  • Mean Hs-C Reactive Protein in Blood [ Time Frame: 0 weeks ]
    Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.
  • Mean Leptin in Blood [ Time Frame: 0 weeks ]
    Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.
  • Mean Plasminogen Activator Inhibitor-1 in Blood [ Time Frame: 0 weeks ]
    Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.
Not Provided
Not Provided
Not Provided
 
Prothrombotic Inflammatory Markers in Women With Metabolic Syndrome - Effect of Atorvastatin
Interactions of Thrombogenic, Lipogenic, and Inflammatory Markers in Women With the Metabolic Syndrome - Effect of Atorvastatin

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.
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.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Metabolic Syndrome
  • Drug: Atorvastatin
    80mg
    Other Name: Lipitor
  • Other: Placebo
    80mg
  • Experimental: Atorvastatin
    44 women randomized to 80 mg atorvastatin for 6weeks
    Intervention: Drug: Atorvastatin
  • Placebo Comparator: sugar pill
    44 women randomized to placebo for 6 weeks
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
116
May 2013
December 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 75 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01785615
Protocol No. 1988
Grant# 2004-1035 ( Other Grant/Funding Number: RSRB 29937 )
Yes
Not Provided
Not Provided
Gladys Velarde, University of Rochester
University of Rochester
Pfizer
Principal Investigator: Gladys P Velarde, MD University of Rochester
University of Rochester
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP