The purpose of this study is to investigate the dose-related effect of treatment with rosuvastatin on production and fractional catabolism of apolipoprotein A-I (apoA-I) and apolipoprotein A-II (apoA-II), and on the plasma apoA-I, apoA-II and high-density lipoprotein cholesterol (HDL-C) concentration.
A Randomised, Double-Blind, Placebo Controlled, Crossover Dose-Ranging Study to Investigate the Effect of Rosuvastatin (CRESTOR) on High Density Lipoprotein Kinetics in Patients With the Metabolic Syndrome
Metabolic Syndrome, Dyslipidemia
Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Primary Outcome Measures:
- Determine the dose-related effect of treatment with rosuvastatin on production & fractional catabolism of apolipoprotein A-I (apoA-I) and apolipoprotein A-II (apoA-II), & on the plasma apoA-I, apoA-II & high-density lipoprotein cholesterol (HDL-C) c
Secondary Outcome Measures:
- Determine the dose-related effect of treatment with rosuvastatin on cellular cholesterol efflux,total cholesterol, low-density lipoprotein cholesterol (LDL-C), non-LDL-C, triglyceride & pre1-HDL concentrations,HDL2,HDL3 cholesterol ratio
- Cholesteryl ester transfer protein (CETP) and lecithin:cholesterol acyl transferase (LCAT) activity
- Lathosterol and campesterol, total apolipoprotein B (apoB), nonesterified fatty acids (NEFA) and apolipoprotein C-III (apoC-III) plasma concentrations.
Eligibility & Criteria
- Ages Eligible for Study: 30 Years – 70 Years
- Genders Eligible for Study: Male
- Accepts Healthy Volunteers
- Signed informed consent
- male aged 30 to 70 years of age
- LDL-C <6 mmol/L
- HDL-C <1.2 mmol/L
- at least 2 of the following: insulin resistance (fasting glucose >6 mmol/L or insulin >10 mU/L or HOMA score >2.5), central obesity (waist circumference >=94 cm), plasma triglycerides >=1.7 and <4.5 mmol/L, blood pressure >=130/ >=85 mm Hg or on drug treatment for hypertension
- LDL cholesterol >=6 mmol/L
- pre-existing or history of cardiovascular disease, diabetes, renal dysfunction, anaemia, history of significant dyspepsia or gastrointestinal disease
- apolipoprotein genotype E2/E2
- Perth, Western Australia
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