The goal of this clinical trial is to learn if empagliflozin works to treat non-alcoholic steatohepatitis in adults. The objectives are: Primary Objective To evaluate the change in histological grading and staging of NASH in patients with confirmed non-alcoholic steatohepatitis (NASH) treated with empagliflozin for a duration of 48 weeks. Secondary Objective To evaluate the change in findings from non-invasive liver elasticity measurements, laboratory tests, and anthropometric assessments after 48 weeks of empagliflozin administration. Participants will: Take empagliflozin every day for 12 months. Visit the clinic according to a protocol at weeks: 1, 2, 4, 12, 24, 36, 48 Visits includes checkups and tests (blood count, basic biochemistry, glycosylated hemoglobin, anthropometry, non-invasive liver stiffness measurement).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Use of empagliflozin 10 mg daily for 12 months.
Central Military Hospital
Prague, Czechia
Change in histological activity after 12-month treatment with empagliflozin
Non-alcoholic Fatty Liver Disease Activity Score (NAS) change after intervention. The NAS can range from 0 to 8 and is calculated by the sum of scores of steatosis (0-3), lobular inflammation (0-3) and hepatocyte ballooning (0-2). In patients with NAFLD, NAS score of ≥ 5 strongly correlated with a diagnosis of "definite NASH" whereas NAS ≤ 3 correlated with a diagnosis of "not NASH".
Time frame: 12 months
Change of liver stiffness
Liver stiffness measured in kilopascals (kPa) by transient elastography at baseline and after intervention.
Time frame: 12 months
Change of liver steatosis
Continuous attenuation parameter measured in decibels per meter (dB/m) at baseline and after intervention.
Time frame: 12 months
Anthropometry (body weight)
Measurement of body weight measured in kilograms (kg) and change from baseline.
Time frame: 12 months
Anthropometry (height)
Measurement of body height measured in metres (m) to calculate Body Mass Index (BMI).
Time frame: 12 months
Anthropometry (BMI)
Change in BMI from baseline (measured in kg/m\^2).
Time frame: 12 months
Liver functional tests
Change in activity liver functional tests (LFT) all measured in microkatals per liter (ucat/L) from baseline. These tests comprise: Alanine transaminase (ALT) Aspartate transaminase (AST) Gamma-glutamyl transferase (GGT) Alkaline phosphatase (ALP)
Time frame: 12 months
Bilirubin level
Change in activity concentration of bilirubin measured in micromoles per liter (umol/L) from baseline.
Time frame: 12 months
Lipidogram
Change in cholesterol, LDL cholesterol, HDL cholesterol, triglycerides (measured in mmol/L) from baseline.
Time frame: 12 months
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