Effects of ethyl icosapentate and omega-3-acid ethyl esters on carotid intima-media thickness (IMT) in Japanese type 2 diabetes patients with dislipidemia
Not Applicable
Recruiting
- Conditions
- Type 2 diabetes
- Registration Number
- JPRN-UMIN000031673
- Lead Sponsor
- Yokohama City University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
Not provided
Exclusion Criteria
(1) Patients already taking ethyl icosapentate or omega-3-acid ethyl ester (2) Patients who are bleeding (hemophilia, capillary vulnerability, digestive tract ulcer, urinary tract hemorrhage, hemoptysis, vitreous hemorrhage etc) (3) Patients with allergy to ethyl icosapentate and omega-3-acid ethyl ester (4) Pregnancy or lactation in women (5) Patients with severe complications( liver disease, mental disorder, cancer) (6) Patients with severe ketosis or diabetic coma. (7) Patients with severe infections, perioperative status, or severe trauma (8) Patients whose written imformed consent was obtained. (9) Patients who are judged by an investigator to be inappropriate for this study for any other reason.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparing the two groups of change in mean IMT over 12 months treatment period.
- Secondary Outcome Measures
Name Time Method Change in next items between baseline and 12 months of treatment. 1. Body weigh, BMI, Waist circumference 2. Systolic blood pressure, Diastolic blood pressure 3. Fasting plasma glucose 4. HbA1c 5. Serum insulin 6. C-peptide 7. HOMA-R 8. CPR-index 9. Total cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol, EPA/AA ratio 10. Urin protein, Urine albumin 11. high-sensitive CRP 12. Serum PAI-1 13. carotid max intima-media thickness (IMT) 14. PWV (Pulse wave velocity)