non-diabetes complicated by non-alcoholic fatty liver disease / non-alcoholic steatohepatitis
Conditions
Interventions
The group with SGLT2 inhibitor, diet therapy and exercise therapy for 24 weeks.
The group with diet therapy and exercise therapy for 24 weeks.
Sponsors
Kobe university school of medicine, Diabetes and Endocrinoplogy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)non-diabetes complicated by NAFLD/NASH (2)Patients with BMI more than 22.0 kg/m2
Exclusion criteria
Exclusion criteria: (1)Choronic hepatitis such as liver cirrhosis, viral hepatitis, alcoholic hepatitis (2)Known or suspected abuse of alcohol (3)Treatment with steroid (4)Patients with severe vascular disease such as stroke, myocardial infarction within the past 6 months (5)Impaired liver function, defined as alanine aminotransferase >4 times upper limit of normal, or Child-pugh C cirrhosis (6)Impaired renal function defined as eGFR <45ml/min (7)Treatment with SGLT2 inhibitor or pioglitazone (8)Pregnancy or breast feeding (9)Cancer and other severe disease (10)Patients with mental illness or drug addicts (11)Patients who are difficult to perform MRI examination such as implantable defibrillators and internal metals (12)Others judged unsuitable by researchers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| hepatic fat content (HFC) changes of MRS are evaluated at two points of the baseline and 24 weeks after the start of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| body weight, blood pressure, visceral fat area (VFA), subcutaneous fat area (SFA), pancreatic fat content (PFC), liver fibrosis markers, aspartate aminotransferase, alanine aminotransferase, and gamma glutamyl transpeptidase are evaluated at two points of the baseline and 24 weeks after the start of treatment. | — |
Countries
Japan
Contacts
Public ContactYuko Okada
Kobe medical university Diabetes and Endocrinoplogy
Outcome results
None listed