The primary objective is to evaluate the efficacy of rosuvastatin therapy on plasma lipid profile (Low Density Lipoprotein (LDL), High-Density Lipoprotein (HDL), total cholesterol, triglyceride) in patients with metabolic syndrome.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
97
medication start dose is 10mg. After 6 weeks of treatment will be force-titrated to 20mg.
Research site
Ankara, Besevler, Turkey (Türkiye)
Research site
Kayseri, Erciyes, Turkey (Türkiye)
Research site
Istanbul, Haseki, Turkey (Türkiye)
Research site
Kocaeli, Umuttepe, Turkey (Türkiye)
Basal HDL-cholesterol Level
HDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)
Time frame: Baseline
HDL-cholesterol Level After 3 Months of Rosuvastatin Treatment
HDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time frame: 3 months (from enrollment to last visit)
Basal LDL-cholesterol Level
LDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)
Time frame: Baseline
LDL-cholesterol Level After 3 Months of Rosuvastatin Treatment
LDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time frame: 3 months (from enrollment to last visit)
Basal Total Cholesterol Level
Baseline
Time frame: Total cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)
Total Cholesterol Level After 3 Months of Rosuvastatin Treatment
Total cholesterol after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time frame: 3 months (from enrollment to last visit)
Basal Triglyceride Level
Triglyceride levels before (mean of visit 1 - screening and Visit 2 - enrollment)
Time frame: Baseline
Triglyceride Level After 3 Months of Rosuvastatin Treatment
Triglycerides after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
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Research Site
Izmir, Turkey (Türkiye)
Research Site
Trabzon, Turkey (Türkiye)
Time frame: 3 months (from enrollment to last visit)
Number of Patients Who Reached Target Level of LDL-cholesterol After 3 Months of Rosuvastatin Treatment
Number of patients who reached target level of LDL-cholesterol after 3 months of rosuvastatin treatment. Target level: LDL-cholesterol: \<100 mg/dL; HDL-cholesterol: For males \>40 mg/dL, for females \>50 mg/dL; non-HDL-cholesterol: \<130 mg/dL
Time frame: 3 months (from enrollment to last visit)
Number of Patients Who Reached Target Level of HDL-cholesterol After 3 Months of Rosuvastatin Treatment
Number of patients who reached target level of HDL-cholesterol after 3 months of rosuvastatin treatment
Time frame: 3 months (from enrollment to last visit)
Number of Patients Who Reached Target Level of Non-HDL-cholesterol After 3 Months of Rosuvastatin Treatment
Number of patients who reached target level of non-HDL-cholesterol after 3 months of rosuvastatin treatment
Time frame: 3 months (from enrollment to last visit)
Basal Interleukin 1 (IL-1) Level
IL-1 levels before (Visit 2-enrollment)
Time frame: Baseline
Interleukin 1 (IL-1) Level After 3 Months of Rosuvastatin Treatment
IL-1 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time frame: 3 months (from enrollment to last visit)
Basal Interleukin 6 (IL-6) Level
IL-6 levels before (Visit 2-enrollment)
Time frame: Baseline
Interleukin 6 (IL-6) Level After 3 Months of Rosuvastatin Treatment
IL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time frame: 3 months (from enrollment to last visit)
Basal Interleukin 8 (IL-8) Level
IL-8 levels before (Visit 2-enrollment)
Time frame: Baseline
Interleukin 8 (IL-8) Level After 3 Months of Rosuvastatin Treatment
IL-8 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time frame: 3 months (from enrollment to last visit)
Basal Interleukin 10 (IL-10) Level
IL-10 levels before (Visit 2-enrollment)
Time frame: Baseline
Interleukin 10 (IL-10) Level After 3 Months of Rosuvastatin Treatment
IL-10 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time frame: 3 months (from enrollment to last visit)
Basal Tumor Necrosis Factor (TNF) Level
TNF levels before (Visit 2-enrollment)
Time frame: Baseline
Tumor Necrosis Factor (TNF) Level After 3 Months of Rosuvastatin Treatment
TNF levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time frame: 3 months (from enrollment to last visit)
Basal High Sensitivity C-reactive Protein (Hs-CRP) Level
hs-CRP levels before (Visit 2-enrollment)
Time frame: Baseline
High Sensitivity C-reactive Protein (Hs-CRP) Level After 3 Months of Rosuvastatin Treatment
hs-CRP levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time frame: 3 months (from enrollment to last visit)
Basal LDL-3 Level
LDL subfractions are light (LDL1 and 2), intermediate (LDL3) and small dense LDL (LDL 4, 5, 6 and 7). Small dense LDL (sdLDL)-cholesterol that expresses greater atherogenicity than large buoyant LDL. Large LDL particles are the least likely to cause plaque formation, because LDL particles have to be approximately 25 nm in diameter or smaller to penetrate the artery walls. High sdLDL and decreased large HDL fraction are more common in patients with coronary heart disease than in controls
Time frame: Baseline
LDL-3 Level After 3 Months of Rosuvastatin Treatment
LDL-3 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time frame: 3 months (from enrollment to last visit)
Basal LDL-4 Level
LDL-4 levels before (Visit 2-enrollment)
Time frame: Baseline
LDL-4 Level After 3 Months of Rosuvastatin Treatment
LDL-4 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time frame: 3 months (from enrollment to last visit)
Basal LDL-5 Level
LDL-5 levels before (Visit 2-enrollment)
Time frame: Baseline
LDL-5 Level After 3 Months of Rosuvastatin Treatment
LDL-5 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time frame: 3 months (from enrollment to last visit)
Basal LDL-6 Level
LDL-6 levels before (Visit 2-enrollment)
Time frame: Baseline
LDL-6 Level After 3 Months of Rosuvastatin Treatment
LDL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time frame: 3 months (from enrollment to last visit)
Basal LDL-7 Level
LDL-7 levels before (Visit 2-enrollment)
Time frame: Baseline
LDL-7 Level After 3 Months of Rosuvastatin Treatment
LDL-7 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time frame: 3 months (from enrollment to last visit)
Basal Large HDL Subfraction Level
Large HDL subfraction levels before (Visit 2-enrollment)
Time frame: Baseline
Large HDL Subfraction Level After 3 Months of Rosuvastatin Treatment
Large HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time frame: 3 months (from enrollment to last visit)
Basal Intermediate HDL Subfraction Level
Intermediate HDL subfraction levels before (Visit 2-enrollment)
Time frame: Baseline
Intermediate HDL Subfraction Level After 3 Months of Rosuvastatin Treatment
Intermediate HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time frame: 3 months (from enrollment to last visit)
Basal Small HDL Subfraction Level
Small HDL subfraction levels before (Visit 2-enrollment)
Time frame: Baseline
Small HDL Subfraction Level After 3 Months of Rosuvastatin Treatment
Small HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time frame: 3 months (from enrollment to last visit)
Number of Patients With Adverse Events
Number of patients with any adverse events in 3 months of rosuvastatin treatment
Time frame: 3 months (from enrollment to last visit)