Phase 2
N=175
Prothrombotic Inflammatory Markers in Women With Metabolic Syndrome - Effect of Atorvastatin
Metabolic Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01785615 ↗Enrolled (actual)
175
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Mean Low Density Lipoprotein Cholesterol in Blood — 70; 135 mg/dl
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Atorvastatin (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Rochester
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Low Density Lipoprotein Cholesterol in Blood |
119.9; 133.3 | — |
| PRIMARY Mean Triglycerides in Blood |
94.6; 197.4 | — |
| PRIMARY Mean Apolipoprotein B in Blood |
86.3; 107.2 | — |
| PRIMARY Mean Apolipoprotein B/ Apolipoprotein A1 Ratio in Blood |
0.5; 0.8 | — |
| PRIMARY Mean High Sensitivity C-reactive Protein in Blood |
3095; 4027 | — |
| PRIMARY Mean Waist Circumference |
33.3; 42.6 | — |
| PRIMARY Mean Systolic Blood Pressure |
114.5; 132.3 | — |
| PRIMARY Mean Diastolic Blood Pressure |
74.6; 82.9 | — |
| PRIMARY Mean High Density Lipoprotein Cholesterol in Blood |
66.6; 46.3 | — |
| PRIMARY Mean Fasting Plasma Glucose in Blood |
90; 93 | — |
| PRIMARY Mean Aspartate Aminotransferase in Blood |
20.27; 21.09 | — |
| PRIMARY Mean Alanine Aminotransferase in Blood |
21.59; 23.75 | — |
| PRIMARY Mean Leptin in Blood |
16285.3; 45518.1 | — |
| PRIMARY Mean Soluble Intercellular Adhesion Molecule in Blood |
192; 220 | — |
| PRIMARY Mean Soluble Vascular Adhesion Molecule in Blood |
512.9; 534.4 | — |
| PRIMARY Mean Plasminogen Activator Inhibitor-1 in Blood |
4.5; 6.2 | — |
| PRIMARY Mean Myeloperoxidase in Blood |
43.7; 52.3 | — |
| SECONDARY Mean Waist Circumference |
33.3; 42.6 | — |
| SECONDARY Mean Low Density Lipoprotein Cholesterol in Blood |
119.9; 133.3 | — |
| SECONDARY Mean Triglycerides in Blood |
94.6; 197.4 | — |
| SECONDARY Mean Myeloperoxidase in Blood |
43.7; 52.3 | — |
| SECONDARY Mean Fasting Blood Glucose in Blood |
84.3; 95.7 | — |
| SECONDARY Mean High Density Lipoprotein Cholesterol in Blood |
66.6; 46.3 | — |
| SECONDARY Mean Intercellular Adhesion Molecule in Blood |
179.2; 212.9 | — |
| SECONDARY Mean Systolic Blood Pressure |
114.5; 132.3 | — |
| SECONDARY Mean Diastolic Blood Pressure |
74.6; 82.9 | — |
| SECONDARY Mean Vascular Adhesion Molecule in Blood |
614.8; 525.0 | — |
| SECONDARY Mean Apolipoprotein A-1 in Blood |
172.0; 134.3 | — |
| SECONDARY Mean Apolipoprotein B in Blood |
86.3; 107.2 | — |
| SECONDARY Mean Apolipoprotein B/ Apolipoprotein A1 Ratio in Blood |
0.5; 0.8 | — |
| SECONDARY Mean Hs-C Reactive Protein in Blood |
1761.5; 3586.9 | — |
| SECONDARY Mean Leptin in Blood |
16285.3; 45518.1 | — |
| SECONDARY Mean Plasminogen Activator Inhibitor-1 in Blood |
4.5; 6.2 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Women between the ages of 18-75 with Metabolic syndrome
- Abdominal circumference > 35 in
- Hypertriglyceridemia > 150mg/dl
- HDL 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
Data sourced from ClinicalTrials.gov (NCT01785615). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.