Multicenter Study for Anti-oxidative and Anti-inflammatory Effects of Pitavastatin in Hypercholesterolemic Patients With Metabolic Syndrome
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Aichi Gakuin University
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Thiobarbituric acid reactive substance; high sensitive C-reactive protein
Study Overview
Brief Summary
The purpose of this study is to evaluate anti-oxidative and anti-inflammatory effects of pitavastatin in hypercholesterolemic patients with the metabolic syndrome.
Detailed Description
The metabolic syndrome is defined as a cluster of cardiovascular risk factors including visceral obesity, dyslipidemia, elevated blood pressure and impaired glucose tolerance. Recently, it has been described that oxidative stress and inflammatory reaction, which are important in progression of atherosclerosis, increases in individuals with the metabolic syndrome. Statins might have beneficial effects such as anti-oxidative and anti-inflammatory actions that are independent from their cholesterol-lowering effects. Pitavastatin, a chemically synthesized statin, has potent LDL-cholesterol lowering and also anti-oxidative and anti-inflammatory effects in animal studies. However, the effects of pitavastatin on oxidative stress and inflammatory action in patients with the metabolic syndrome have not been reported.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Hypercholesterolemic patients
Exclusion Criteria
- •Patients receiving lipid-lowering agents
- •Familial hypercholesterolemia
- •Renal disease
- •Diseases of liver, gallbladder and bile ducts
- •Pregnant women
Outcomes
Primary Outcomes
Thiobarbituric acid reactive substance; high sensitive C-reactive protein
Time Frame: 12 weeks
Secondary Outcomes
- Total cholesterol; LDL-cholesterol; HDL-cholesterol; triglyceride;(12 weeks)
- Homeostasis model assessment for insulin resistance; adiponectin;(12 weeks)
- Soluble intercellular adhesion molecule-1(12 weeks)