Study of the Effects of eicosapentaenoic acid on diabetic atherosclerotic lesio
- Conditions
- Type 2 diabetes
- Registration Number
- JPRN-UMIN000007835
- Lead Sponsor
- Osaka University Graduate School
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 44
Not provided
Patients meeting one of the following conditions will be excluded: 1) type 1 and secondary diabetes, 2) severe infectious disease, before or after surgery, and severe trauma, 3) events of myocardial infarction, angina pectoris, cerebral stroke, and cerebral infarction, 4) moderate or severe renal dysfunction (serum creatinine (mg/dL): male, 1.4<; female, 1.2<), 5) severe liver dysfunction (AST: 100 IU/l or higher), 6) moderate or severe heart failure) (NYHA/New York Heart Association stage III or severer), 7) under treatment with an EPA preparation at the time of study initiation, 8) pregnant, lactating, and possibly pregnant women and those planning to become pregnant, 9) patients with bleeding (hemophilia, gastrointestinal ulceration, urinary tract bleeding, hemoptysis, vitreous hemorrhage, etc.), 10) past medical history of hypersensitivity to investigational drugs, 11) judged as ineligible by clinical investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in the calibrated-IBS value measured at the thickest site of the carotid artery during a 12-months treatment period
- Secondary Outcome Measures
Name Time Method