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Effects of ethyl icosapentate and omega-3-acid ethyl esters on carotid intima-media thickness (IMT) in Japanese type 2 diabetes patients with dislipidemia

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Type 2 diabetes
Date of first enrollment	2018/03/09
Target sample size	120
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	ethyl icosapentate 1.8g/day, 12 months omega-3-acid ethyl ester 2g/day, 12 months

Outcome(s)

Primary Outcome

Comparing the two groups of change in mean IMT over 12 months treatment period.

Secondary Outcome

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)

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	Not applicable
Gender	Male and Female
Include criteria
Exclude 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.