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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NASH | Experimental | Patients with histological proven NASH (either diabetics and non-diabetics). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin 10 miligrams (mg) | Drug | Use of empagliflozin 10 mg daily for 12 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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". | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change of liver stiffness | Liver stiffness measured in kilopascals (kPa) by transient elastography at baseline and after intervention. | 12 months |
| Change of liver steatosis | Continuous attenuation parameter measured in decibels per meter (dB/m) at baseline and after intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Military Hospital | Prague | 16902 | Czechia |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D008107 | Liver Diseases |
| D003924 | Diabetes Mellitus, Type 2 |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D004066 | Digestive System Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
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| 12 months |
| Anthropometry (body weight) | Measurement of body weight measured in kilograms (kg) and change from baseline. | 12 months |
| Anthropometry (height) | Measurement of body height measured in metres (m) to calculate Body Mass Index (BMI). | 12 months |
| Anthropometry (BMI) | Change in BMI from baseline (measured in kg/m^2). | 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) | 12 months |
| Bilirubin level | Change in activity concentration of bilirubin measured in micromoles per liter (umol/L) from baseline. | 12 months |
| Lipidogram | Change in cholesterol, LDL cholesterol, HDL cholesterol, triglycerides (measured in mmol/L) from baseline. | 12 months |
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |