The effect of empagliflozin on nonalcoholic fatty liver disease in diabetic patients

Phase 2

Conditions: Condition 1: Nonalcoholic fatty liver disease. Condition 2: Diabetes type 2.
Nonalcoholic steatohepatitis [NASH]
Type 2 diabetes mellitus
K75.81

Registration Number: IRCT20190122042450N3

Lead Sponsor: Iran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 105

Inclusion Criteria

Age 20-65
Body mass index less than 40
Alcohol daily consumption less than 20 g in women and less than 30 g in men, for at least 3 consecutive months over 5 years ago
Hemoglobin A1c 7-10 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

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.
Diabetes type 1 or secondary diabetes
Consumption of corticosteroid for 14 days over 2 months ago
biliary obstruction in liver and gallbladder sonography

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of CAP (Controlled attenuation parameter). Timepoint: at start and 24 weeks. Method of measurement: with fibroscan.

Secondary Outcome Measures

Name	Time	Method
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.