Patients of type 2 diabetes mellitus with nonalcoholic fatty liver disease (NAFLD).
Conditions
Interventions
canagliflozin100mg/day
Sponsors
Department of Endocrinology, Diabetes and Metabolism, Kitasato University School of Medicine.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1: Type 2 diabetes 2: Patients with NAFLD diagnosed by clinical data 3: Patients provided with informed consent
Exclusion criteria
Exclusion criteria: 1: Diabetic ketoacidosis and hyperosmolar hyperglycemic state 2: Insulin dependent diabetes 3: Before and after surgery and severe trauma 4: Taking excessive alcohol 5: Severe renal failure or undergoing hemodialysis 6: Proliferative diabetic retinopathy 7: Obvious orthostatic hypotension 8: Patient who cannot be ruled out other liver disease including viral hepatitis, autoimmune hepatitis, a drug-induced hepatitis. 9: Severe hepatic dysfunction 10: Malignant neoplasm 11: Women who have a possibility of pregnancy or is pregnant 12: Allergy to SGLT2 inhibitors, having a recent history of taking SGLT2 inhibitors 13: Patient who is suspected type 1 diabetes and other diabetes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hepatic fat fraction (HFF) by hepatic magnetic resonance imaging (MRI) after 6 or 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| body weight, HbA1c, glucagon, type IV collagen, hyaluronic acid and NAFLD fibrosis score. | — |
Countries
Japan
Contacts
Public ContactMitsuko Inoue
Kitasato University School of Medicine. Department of Endocrinology, Diabetes and Metabolism.
Outcome results
None listed