Effect of SGLT-2 inhibitors on Hepatic Steatosis and Fibrosis Estimated by using Fibroscan with Type 2 Diabetes Suffering from Non-alcoholic Fatty Liver Disease
Not Applicable
- Conditions
- Type 2 Diabetes Suffering from Non-alcoholic Fatty Liver Disease
- Registration Number
- JPRN-UMIN000022155
- Lead Sponsor
- Dokkyo Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
1) Type 1 diabetes 2) Severe diabetic complications such as ketoacidosis 3) Severe renal dysfunction(estimated glomerular filtration rate [eGFR] < 30 mL/min/) 4) Pregnant or nursing women and those who might be pregnant 5) Chronic heart failure, 6) Haemodialysis, 7) A history of stroke and cardiovascular events, 8) Any patient whom the investigator judged to be inappropriate for this study. Patients were given detailed explanations of the study protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The change of hepatic steatosis between SGLT-2 inhibitors group(Additional treatment with SGLT-2 inhibitor) and control group (aggressive conventional treatment without SGLT-2 inhibitors) at 24 weeks after starting this trial.
- Secondary Outcome Measures
Name Time Method The change of visceral fat area The change of body composition The change of endothelial function The change of NAFLD fibrosis score,NAFIC score,FIB-4index and M2BPGi The change of oxidative,apoptosis markers and inflammatory cytokines. These changes will be evaluated at base line, 24 weeks between two groups