Effects of an Inhibitor of Sodium-glucose Cotransporter 2 for Type 2 Diabetes Mellitus with Nonalcoholic Fatty Liver Disease (NAFLD).
Not Applicable
Recruiting
- Conditions
- Patients of type 2 diabetes mellitus with nonalcoholic fatty liver disease (NAFLD).
- Registration Number
- JPRN-UMIN000020615
- Lead Sponsor
- Department of Endocrinology, Diabetes and Metabolism, Kitasato University School of Medicine.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hepatic fat fraction (HFF) by hepatic magnetic resonance imaging (MRI) after 6 or 12 months.
- Secondary Outcome Measures
Name Time Method body weight, HbA1c, glucagon, type IV collagen, hyaluronic acid and NAFLD fibrosis score.