Nonalcoholic fatty liver disease Nonalcoholic steatohepatit NAFLD NASH type 2 DM
Conditions
Interventions
SGLT2 inhibitor, vitamin E
Sponsors
Ikejima Kenichi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: HbA1c>=6.5% after dietary exercise during pre-observation period (8 to 16 weeks), hepatic steatosis in abdominal US
Exclusion criteria
Exclusion criteria: 1.ethanol consumption over 30g/d in Male or 20g/d in Female 2.type 1 diabetic patients 3. poor glycemic control HbA1c>=8.4% 4.patients who are being treated for liver disease other than NAFLD 5.Male: serum creatinine higher than 1.2mg/dL Female: serum creatinine higher than 1.0mg/dL patients 6.Patients who cannot be aware of dry mouth 7.SGLT2 inhibitor contraindication case 8.Patients with a history of hypersensitivity to SGLT2 inhibitor/Vit. E 9.Patients judged to be ineligible by a doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of serum AST, ALT, ALP, gammaGTP, type IV collagen, M2BPGi, Fib4 index, adverse effect | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of body weight, fasting plasma glucose (FPG), insulin, triacylglycerol (TG), non-esterified fatty acid, HDL-cholesterol, LDL-cholesterol, leptin, CAP, liver stiffness visceral fat amount | — |
Contacts
Public ContactKazuyoshi Kon
Juntendo University Hospital
Outcome results
None listed