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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000031673

Enrollment

120

Registered

2018-03-13

Start date

2018-03-09

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Interventions

ethyl icosapentate 1.8g/day, 12 months omega-3-acid ethyl ester 2g/day, 12 months

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Japanese type2 diabetes patients with hypertriglyceridemia(over 150mg/dl)

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Comparing the two groups of change in mean IMT over 12 months treatment period.	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

Japan

Contacts

Public ContactMayu Kyohara

Yokohama City University Graduate School of Medicine Department of Endocrinology and Metabolism

kyouhara-tym@umin.ac.jp045-787-2800

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026