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The effect of Empagliflozin on nonalcoholic fatty liver disease in non-diabetic patients

Phase 2
Not yet recruiting
Conditions
on alcoholic fatty liver disease.
Nonalcoholic steatohepatitis [NASH]
K75.81
Registration Number
IRCT20190122042450N1
Lead Sponsor
Iran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
100
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

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.

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change of CAP (Controlled attenuation parameter). Timepoint: at start and 24 weeks. Method of measurement: with fibroscan.
Secondary Outcome Measures
NameTimeMethod
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.
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