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Impact of Pitavastatin in Hypercholesterolemic Patients With Metabolic Syndrome

Phase 4
Completed
Conditions
Metabolic Syndrome
Oxidative Stress
Inflammation
Registration Number
NCT00444717
Lead Sponsor
Aichi Gakuin University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
100
Inclusion Criteria
  • Hypercholesterolemic patients
Exclusion Criteria
  • Patients receiving lipid-lowering agents
  • Familial hypercholesterolemia
  • Renal disease
  • Diseases of liver, gallbladder and bile ducts
  • Pregnant women

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Thiobarbituric acid reactive substance; high sensitive C-reactive protein12 weeks
Secondary Outcome Measures
NameTimeMethod
Total cholesterol; LDL-cholesterol; HDL-cholesterol; triglyceride;12 weeks
Homeostasis model assessment for insulin resistance; adiponectin;12 weeks
Soluble intercellular adhesion molecule-112 weeks

Trial Locations

Locations (1)

Tatsuaki Matsubara

🇯🇵

Nagoya, Aichi, Japan

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