The effect of eicosapentaenoic acid on insulin sensitivity in patients with type2 diabetes mellitus and dyslipidemia: a randomized cross-over clinical trial.
- Conditions
- Type2 diabetes and dyslipidemia
- Registration Number
- JPRN-UMIN000015673
- Lead Sponsor
- Kanazawa university Department of Disease Control and Homeostasis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
1. Patients who have history of serious hypersensitivity to EPA. 2. Patients with diabetic ketoacidosis. 3. Patients who have history of severe hypoglycemia with coma or loss of consciousness. 4. Patients with serious infection or severe traumatic injury. 5. Patients who had EPA medication within 8 weeks before entry. 6. Patients with poor glysemic control and identified inappropriate for this study by the physicians in charge. 7. Patients with peritonial dialysis or hemodialysis or severe renal failure like CCR < 30ml/min, sCR <2.5mg/dL for male, or <2.0mg/dL for female. 8. Patients with unstable hypertension with medication like systolic blood pressure above 160 mmHg or diastolic blood pressure above 100mmHg. 9. Patients with severe heart failure like NYHA III or IV, unstable angina, history of myocardial infarction within 1 year. 10. Patients with proliferative retinopathy (excluding old proliferative retinopathy without necessary of intervention) and patients with maculopathy with necessary of intervention 11. Patients who have history of malignancy, except for patients who have history of cured basal cell tumor by appropriate treatment or uterocervical carcinoma in situ or malignancy more than 1 year before and also have no reappearance. 12. Patients with severe complication and identified inappropriate patients for this study by the physicians in charge. 13. The pregnant women or women having possibilities of being pregnant and the women with breast-feeding. 14. Other patients who are identified inappropriate patients for this study by the physicians in charge.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method