Metabolic Syndrome
Conditions
Keywords
metabolic syndrome, atorvastatin, women
Brief 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.
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 (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.
Interventions
DRUGAtorvastatin
80mg
OTHERPlacebo
80mg
Sponsors
Pfizer
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Myeloperoxidase in Blood | 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 Low Density Lipoprotein Cholesterol in Blood | 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 | 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 | 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 | 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 | 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 | 6 weeks | Waist circumference was measured with a ruler tape. |
| Mean Systolic Blood Pressure | 6 weeks | Measured with a blood pressure cuff |
| Mean Diastolic Blood Pressure | 6 weeks | Measured with a blood pressure cuff |
| Mean High Density Lipoprotein Cholesterol in Blood | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Low Density Lipoprotein Cholesterol in Blood | 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 | 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 | 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 | 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 | 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 | 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 | 0 weeks | Measured with a blood pressure cuff |
| Mean Diastolic Blood Pressure | 0 weeks | Measured with a blood pressure cuff |
| Mean Vascular Adhesion Molecule in Blood | 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 | 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 | 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 | 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 | 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 | 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 | 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 Waist Circumference | week 0 | Waist circumference was measured with a ruler tape. |
Countries
United States
Participant flow
Recruitment details
Approximately 250 women volunteers were screened and 140 were selected to go on to the first phase of the trial. After a 6-week period of a run in diet phase, 24 did not return to start randomization. Out of 116 women, 6 failed to meet MBS criteria by one ATP III element.
Participants by arm
| Arm | Count |
|---|---|
| Atorvastatin 44 women randomized to 80 mg atorvastatin for 6weeks
Atorvastatin : 80mg | 44 |
| Sugar Pill 44 women randomized to placebo for 6 weeks
Placebo : 80mg | 44 |
| Healthy Participants | 35 |
| Total | 123 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Dietary Phase | Lost to Follow-up | 0 | 0 | 0 | 24 |
Baseline characteristics
| Characteristic | Atorvastatin | Sugar Pill | Healthy Participants | Total |
|---|---|---|---|---|
| Age, Continuous | 51 years STANDARD_DEVIATION 9 | 52 years STANDARD_DEVIATION 9 | 53.7 years STANDARD_DEVIATION 9 | 52.1 years STANDARD_DEVIATION 9 |
| Region of Enrollment United States | 44 participants | 44 participants | 35 participants | 88 participants |
| Sex: Female, Male Female | 44 Participants | 44 Participants | 35 Participants | 123 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 44 | 0 / 44 |
| serious Total, serious adverse events | 0 / 44 | 0 / 44 |
Outcome results
Primary
Mean Alanine Aminotransferase in Blood
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atorvastatin | Mean Alanine Aminotransferase in Blood | 21.59 units/L | Standard Deviation 9.1 |
| Sugar Pill | Mean Alanine Aminotransferase in Blood | 23.75 units/L | Standard Deviation 9.62 |
Primary
Mean Apolipoprotein B/ Apolipoprotein A1 Ratio in Blood
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atorvastatin | Mean Apolipoprotein B/ Apolipoprotein A1 Ratio in Blood | 0.48 ratio | Standard Deviation 0.18 |
| Sugar Pill | Mean Apolipoprotein B/ Apolipoprotein A1 Ratio in Blood | 0.86 ratio | Standard Deviation 0.19 |
Primary
Mean Apolipoprotein B in Blood
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atorvastatin | Mean Apolipoprotein B in Blood | 63 mg/dl | Standard Deviation 23 |
| Sugar Pill | Mean Apolipoprotein B in Blood | 110 mg/dl | Standard Deviation 23 |
Primary
Mean Aspartate Aminotransferase in Blood
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atorvastatin | Mean Aspartate Aminotransferase in Blood | 20.27 units/L | Standard Deviation 5.73 |
| Sugar Pill | Mean Aspartate Aminotransferase in Blood | 21.09 units/L | Standard Deviation 7.12 |
Primary
Mean Diastolic Blood Pressure
Measured with a blood pressure cuff
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atorvastatin | Mean Diastolic Blood Pressure | 83.16 mm Hg | Standard Deviation 8.67 |
| Sugar Pill | Mean Diastolic Blood Pressure | 81.86 mm Hg | Standard Deviation 8.14 |
Primary
Mean Fasting Plasma Glucose in Blood
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atorvastatin | Mean Fasting Plasma Glucose in Blood | 90 mg/dl | Standard Deviation 25.2 |
| Sugar Pill | Mean Fasting Plasma Glucose in Blood | 93 mg/dl | Standard Deviation 16 |
Primary
Mean High Density Lipoprotein Cholesterol in Blood
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atorvastatin | Mean High Density Lipoprotein Cholesterol in Blood | 46.4 mg/dl | Standard Deviation 8.96 |
| Sugar Pill | Mean High Density Lipoprotein Cholesterol in Blood | 44.2 mg/dl | Standard Deviation 9.35 |
Primary
Mean High Sensitivity C-reactive Protein in Blood
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
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atorvastatin | Mean High Sensitivity C-reactive Protein in Blood | 3095 ng/dl | Standard Deviation 1778.8 |
| Sugar Pill | Mean High Sensitivity C-reactive Protein in Blood | 4027 ng/dl | Standard Deviation 1583.8 |
Primary
Mean Leptin in Blood
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atorvastatin | Mean Leptin in Blood | 43077 pg/ml | Standard Deviation 24706.7 |
| Sugar Pill | Mean Leptin in Blood | 46721.3 pg/ml | Standard Deviation 22137.6 |
Primary
Mean Low Density Lipoprotein Cholesterol in Blood
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atorvastatin | Mean Low Density Lipoprotein Cholesterol in Blood | 70 mg/dl | Standard Deviation 24.8 |
| Sugar Pill | Mean Low Density Lipoprotein Cholesterol in Blood | 135 mg/dl | Standard Deviation 31.4 |
Primary
Mean Myeloperoxidase in Blood
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atorvastatin | Mean Myeloperoxidase in Blood | 52.18 ng/ml | Standard Deviation 16.1 |
| Sugar Pill | Mean Myeloperoxidase in Blood | 59.19 ng/ml | Standard Deviation 16.56 |
Primary
Mean Plasminogen Activator Inhibitor-1 in Blood
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atorvastatin | Mean Plasminogen Activator Inhibitor-1 in Blood | 6.18 ng/ml | Standard Deviation 0.93 |
| Sugar Pill | Mean Plasminogen Activator Inhibitor-1 in Blood | 6.60 ng/ml | Standard Deviation 1.03 |
Primary
Mean Soluble Intercellular Adhesion Molecule in Blood
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atorvastatin | Mean Soluble Intercellular Adhesion Molecule in Blood | 192 ng/ml | Standard Deviation 64 |
| Sugar Pill | Mean Soluble Intercellular Adhesion Molecule in Blood | 220 ng/ml | Standard Deviation 58 |
Primary
Mean Soluble Vascular Adhesion Molecule in Blood
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atorvastatin | Mean Soluble Vascular Adhesion Molecule in Blood | 512.9 ng/ml | Standard Deviation 121.6 |
| Sugar Pill | Mean Soluble Vascular Adhesion Molecule in Blood | 534.4 ng/ml | Standard Deviation 116 |
Primary
Mean Systolic Blood Pressure
Measured with a blood pressure cuff
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atorvastatin | Mean Systolic Blood Pressure | 130.9 mm Hg | Standard Deviation 13.03 |
| Sugar Pill | Mean Systolic Blood Pressure | 130.4 mm Hg | Standard Deviation 13.3 |
Primary
Mean Triglycerides in Blood
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atorvastatin | Mean Triglycerides in Blood | 139 mg/dl | Standard Deviation 54.84 |
| Sugar Pill | Mean Triglycerides in Blood | 185 mg/dl | Standard Deviation 65.4 |
Primary
Mean Waist Circumference
Waist circumference was measured with a ruler tape.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atorvastatin | Mean Waist Circumference | 41.29 inches | Standard Deviation 5.13 |
| Sugar Pill | Mean Waist Circumference | 42.79 inches | Standard Deviation 4.91 |
Secondary
Mean Apolipoprotein A-1 in Blood
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.
Time frame: 0 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atorvastatin | Mean Apolipoprotein A-1 in Blood | 172.0 mg/dl | Standard Deviation 17.4 |
| Sugar Pill | Mean Apolipoprotein A-1 in Blood | 134.3 mg/dl | Standard Deviation 24 |
Secondary
Mean Apolipoprotein B/ Apolipoprotein A1 Ratio in Blood
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.
Time frame: 0 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atorvastatin | Mean Apolipoprotein B/ Apolipoprotein A1 Ratio in Blood | 0.5 ratio | Standard Deviation 0.1 |
| Sugar Pill | Mean Apolipoprotein B/ Apolipoprotein A1 Ratio in Blood | 0.8 ratio | Standard Deviation 0.2 |
Secondary
Mean Apolipoprotein B in Blood
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.
Time frame: 0 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atorvastatin | Mean Apolipoprotein B in Blood | 86.3 mg/dl | Standard Deviation 14.9 |
| Sugar Pill | Mean Apolipoprotein B in Blood | 107.2 mg/dl | Standard Deviation 23.1 |
Secondary
Mean Diastolic Blood Pressure
Measured with a blood pressure cuff
Time frame: 0 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atorvastatin | Mean Diastolic Blood Pressure | 74.6 mm Hg | Standard Deviation 7.1 |
| Sugar Pill | Mean Diastolic Blood Pressure | 82.9 mm Hg | Standard Deviation 8.3 |
Secondary
Mean Fasting Blood Glucose in Blood
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.
Time frame: 0 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atorvastatin | Mean Fasting Blood Glucose in Blood | 84.3 mg/dl | Standard Deviation 11.4 |
| Sugar Pill | Mean Fasting Blood Glucose in Blood | 95.7 mg/dl | Standard Deviation 21.4 |
Secondary
Mean High Density Lipoprotein Cholesterol in Blood
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.
Time frame: 0 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atorvastatin | Mean High Density Lipoprotein Cholesterol in Blood | 66.6 mg/dl | Standard Deviation 9.4 |
| Sugar Pill | Mean High Density Lipoprotein Cholesterol in Blood | 46.3 mg/dl | Standard Deviation 10.1 |
Secondary
Mean Hs-C Reactive Protein in Blood
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.
Time frame: 0 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atorvastatin | Mean Hs-C Reactive Protein in Blood | 1761.5 ng/ml | Standard Deviation 1520.4 |
| Sugar Pill | Mean Hs-C Reactive Protein in Blood | 3586.9 ng/ml | Standard Deviation 1531.7 |
Secondary
Mean Intercellular Adhesion Molecule in Blood
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.
Time frame: 0 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atorvastatin | Mean Intercellular Adhesion Molecule in Blood | 179.2 ng/ml | Standard Deviation 39.9 |
| Sugar Pill | Mean Intercellular Adhesion Molecule in Blood | 212.9 ng/ml | Standard Deviation 70.2 |
Secondary
Mean Leptin in Blood
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.
Time frame: 0 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atorvastatin | Mean Leptin in Blood | 16285.3 pg/ml | Standard Deviation 13317.9 |
| Sugar Pill | Mean Leptin in Blood | 45518.1 pg/ml | Standard Deviation 25798.8 |
Secondary
Mean Low Density Lipoprotein Cholesterol in Blood
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.
Time frame: 0 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atorvastatin | Mean Low Density Lipoprotein Cholesterol in Blood | 119.9 mg/dl | Standard Deviation 24.4 |
| Sugar Pill | Mean Low Density Lipoprotein Cholesterol in Blood | 133.3 mg/dl | Standard Deviation 33.9 |
Secondary
Mean Myeloperoxidase in Blood
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.
Time frame: 0 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atorvastatin | Mean Myeloperoxidase in Blood | 43.7 ng/ml | Standard Deviation 9.8 |
| Sugar Pill | Mean Myeloperoxidase in Blood | 52.3 ng/ml | Standard Deviation 17.1 |
Secondary
Mean Plasminogen Activator Inhibitor-1 in Blood
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.
Time frame: 0 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atorvastatin | Mean Plasminogen Activator Inhibitor-1 in Blood | 4.5 ng/ml | Standard Deviation 0.7 |
| Sugar Pill | Mean Plasminogen Activator Inhibitor-1 in Blood | 6.2 ng/ml | Standard Deviation 1.1 |
Secondary
Mean Systolic Blood Pressure
Measured with a blood pressure cuff
Time frame: 0 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atorvastatin | Mean Systolic Blood Pressure | 114.5 mm Hg | Standard Deviation 12.6 |
| Sugar Pill | Mean Systolic Blood Pressure | 132.3 mm Hg | Standard Deviation 82.9 |
Secondary
Mean Triglycerides in Blood
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.
Time frame: 0 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atorvastatin | Mean Triglycerides in Blood | 94.6 mg/dl | Standard Deviation 53.1 |
| Sugar Pill | Mean Triglycerides in Blood | 197.4 mg/dl | Standard Deviation 101.6 |
Secondary
Mean Vascular Adhesion Molecule in Blood
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.
Time frame: 0 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atorvastatin | Mean Vascular Adhesion Molecule in Blood | 614.8 ng/ml | Standard Deviation 108.9 |
| Sugar Pill | Mean Vascular Adhesion Molecule in Blood | 525.0 ng/ml | Standard Deviation 127.4 |
Secondary
Mean Waist Circumference
Waist circumference was measured with a ruler tape.
Time frame: week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atorvastatin | Mean Waist Circumference | 33.3 inches | Standard Deviation 5.3 |
| Sugar Pill | Mean Waist Circumference | 42.6 inches | Standard Deviation 5.7 |