Type2 diabetes and dyslipidemia
Conditions
Interventions
oral EPA administration for 3 months then ceasing EPA for 3 months
follow up for 3 months then starting oral EPA administration
Sponsors
Kanazawa university Department of Disease Control and Homeostasis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Type2 diabetes with dyslipidemia (TG>= 150 mg/dL) within 8 weeks before entry
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in hepatokine | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in insulin sensitivity assessed by the glucose clamp technique 2. Blood glucose control (FPG, IRI, HbA1c) 3. Change in lipid metabolism (TC, HDL-C, TG, EPA/AA ratio) 4. Change in physical findings by change of body weight, adipose mass, basal metabolism and waist circumference 5. Change in biochemical finding 6. Adverse events 7. Change in fecal metabolome | — |
Countries
Japan
Contacts
Public ContactToshinari Takamura
Kanazawa university Department of Disease Control and Homeostasis
Outcome results
None listed