Non-
Conditions
Interventions
Patients will be prescribed with 1 tab of canagliflozin (100 mg) or once daily for 24 weeks.
Patients will also be encouraged to reduce 500-
1000 calories from daily intake and have moderate intensity exercise at least 150 minutes per week. ,Patients will be prescribed with 1 tab of placebo once daily for 24 weeks.
Patients will be encoura
1000 calories from daily intake and have moderate intensity exercise at least 150 minutes per week.
Experimental Drug,Placebo Comparator Drug
Sponsors
Ratchadaphiseksomphot Endowment Fund
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-80 years old 2. BMI 25-35 kg/m2 3. Evidence of hepatic steatosis by imaging (ultrasound, CT or MRI) 4. CAP values above 200 dB/m
Exclusion criteria
Exclusion criteria: 1. Evidence of liver cirrhosis by ultrasound or Fibroscan (LSM > 12 kPa) 2. Estimated GFR 30g/day and female patients with alcohol consumption >20g/day using AUDIT, Skinner alcohol question 6. Chronic B viral hepatitis or evidence of previous infection, chronic C viral hepatitis, autoimmune liver disease, hemochromatosis, Wilson's disease and other liver diseases 7. Exposure to drug induced steatohepatitis with in the previous 6 months: Aspirin, Amiodarone, Chemotherapy (5-fluorouracil, tamoxifen, irinotecan, cisplatin, and asparaginase, irinotecan), Cocaine, Glucocorticoids, Methotrexate, Nucleoside reverse transcriptase inhibitors (NRTI), Tetracycline (Intravenous administration of high doses), Total parenteral nutrition, and Valproic acid 8. Weight gain or loss ≥5 kg in last 6 months 9. Current or previous use following drugs within the past 6 months: SGLT2 inhibitor, pioglitazone, vitamin E, and liraglutide 10. Patient underwent bariatric surgery within 5 years 11. History of diabetic ketoacidosis 12. History of peripheral arterial disease or lower limb amputation 13. History of recurrent urinary tract infection 14. History of fungal infection in genital area 15. Documented genitourinary tract structural abnormality 16. Pregnant women or nursing mothers 17. Patients do not provide a written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Controlled Attenuation Parameter (CAP) at start and end of study Fibroscan (db/m) | — |
Secondary
| Measure | Time frame |
|---|---|
| liver stiffness at start and end of study kPa,NAFLD fibrosis score at start, 3 months and end of study Calculation from parameters,Fibrosis-4 (FIB-4) Index at start, 3 months and end of study Calculation from parameters | — |
Countries
Thailand
Contacts
Public ContactBorwonkhun Tontivuthikul
King Chulalongkorn memorial hospital
Outcome results
None listed