Non alcoholic fatty liver disease. Nonalcoholic steatohepatitis [NASH]
Conditions
Interventions
Intervention 1: Intervention group: Empagliflozin 10 milligram, Dr. Abidi pharmacy over 6 months. Intervention 2: Control group: placebo, Dr. Abidi pharmacy over 6 months.
Sponsors
Iran University of Medical Sciences
Abidi pharmacy
Eligibility
Sex/Gender
All
Age
20 Years to 65 Years
Inclusion criteria
Inclusion criteria: Age 20-65 Body mass index less than 40 Alcohol daily consumption <20 g in women and < 30 g in men, for at least 3 consecutive months over 5 years ago Hemoglobin A1c less than 6.5 percent Alanin aminotransferase more than 45 in men and more than 30 in women Creatinin less than 1.5 in men and less than 1.4 in women and glomerular filtration rate more than 45 Controlled atenuated parameter more than 230 in fibroscan or fatty liver grade equal and more than 2 in liver sonography Signature of consent form
Exclusion criteria
Exclusion criteria: Pregnancy, breast feeding Heart failure (class II to IV) History of cardiovascular disease in 3 months ago History of cancer in 2 years ago History of cirrhosis Abnormal TSH (uncontrolled yper or hypothyroidism) Autoimmune hepatitis (abnormal ANA and ASMA) Hepatitis C (positive HCV Ab) Hepatitis B (positive HBS Ag) Consumption of NSAIDs, Amiodarone, Tamoxifen, Fibrate, statin, Zinc, Selenium and vitamin C or other antioxidant drugs, Empagliflozin, Metformin, Pioglitazone, Vitamin E and other fatty liver drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of CAP (Controlled attenuation parameter). Timepoint: at start and 24 weeks. Method of measurement: with fibroscan. | — |
Secondary
| Measure | Time frame |
|---|---|
| Weight. Timepoint: start and 12 weeks and 24 weeks after intervention. Method of measurement: with weight scale.;Nonalcoholic fatty liver disease fibrosis score. Timepoint: start and 24 weeks after intervention. Method of measurement: with use of labroatary tests and formula of the NAFLD fibrosis score.;FIB4 index. Timepoint: start and 24 weeks after intervention. Method of measurement: with use of labroatary tests and formula of the FIB4.;A/G (Android/Gynoid). Timepoint: start and 24 weeks after intervention. Method of measurement: with Dual-energy X-ray absorptiometry (DEXA).;Liver stiffness measurement (LSM). Timepoint: start and 24 weeks after intervention. Method of measurement: Liver fibroscan.;VAT (Visceral adipose tissue). Timepoint: start and 24 weeks after intervention. Method of measurement: with Dual-energy X-ray absorptiometry (DEXA).;Body mass index. Timepoint: start and 12 weeks and 24 weeks after intervention. Method of measurement: with weight and height scale and formula. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSeyedeh Hoda Taheri
Iran University of Medical Sciences
Outcome results
None listed