Reducing Non-Alcoholic Steatohepatitis
- Conditions
- Non-alcoholic SteatohepatitisLiver DiseasesDiabetes Mellitus, Type 2Fibrosis, Liver
- Interventions
- Registration Number
- NCT06519448
- Lead Sponsor
- Military University Hospital, Prague
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 30
- Ability and eligibility to provide informed consent.
- Age between 18 and 75 years at the time of study initiation.
- Confirmed or excluded diagnosis of type 2 diabetes mellitus (DM2) according to the target group (OGTT test, HbA1c).
- Diagnosis of NASH confirmed by a central pathologist based on histological evaluation of a liver biopsy performed within 3 months prior to the initiation of the investigational drug. - The evaluation must include determination of the process activity according to the NAFLD Activity Score (NAS).
- HbA1c value ≤ 80 mmol/mol.
- For women of childbearing potential, willingness to use at least two adequate methods of contraception.
- Contraindication to liver biopsy.
- Documented episode of ketoacidosis.
- Contraindication or hypersensitivity to empagliflozin.
- Presence of acute or chronic illness that, in the investigator's opinion, could jeopardize the health or safety of the patient.
- HbA1c value > 80 mmol/mol.
- Inability to safely discontinue thiazolidinedione (pioglitazone) therapy.
- Liver disease of other etiologies, including viral hepatitis B and C, autoimmune hepatitis, alpha-1 antitrypsin deficiency, hemochromatosis, Wilson's disease, primary sclerosing cholangitis, primary biliary cholangitis, or liver cirrhosis (Child-Pugh A, B, C) of any etiology.
- Use of medications or medical procedures that induce liver steatosis or fibrosis.
- Proven alcohol use exceeding: Men > 30 g/day, Women > 20 g/day.
- History of acute or chronic pancreatitis.
- Known dependence on or use of illegal addictive substances.
- Significant weight gain or loss: +/- 10% in the last three months.
- Diagnosis of malignant disease (except treated benign or skin tumors) in the last 5 years.
- Stroke or myocardial infarction in the last 6 months.
- Clinically significant dyspnea New York hear association (NYHA) grade III or higher.
- Proven heart failure with a left ventricular ejection fraction below 40%.
- estimated glomerular filtration rate(eGFR) values lower than 30 ml/min/1.73 m² or creatinine clearance lower than 30 ml/min.
- Proven diabetic foot syndrome requiring amputation or with an existing defect.
- Planned pregnancy, ongoing lactation or pregnancy, positive pregnancy test, lack of at least two adequate contraceptive methods in women of childbearing potential.
- Participation in another interventional study within the last 3 months before study entry.
- Legal incapacity or reduced ability to perform legal acts.
- Serving a prison sentence.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description NASH Empagliflozin 10 miligrams (mg) Patients with histological proven NASH (either diabetics and non-diabetics).
- Primary Outcome Measures
Name Time Method Change in histological activity after 12-month treatment with empagliflozin 12 months 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".
- Secondary Outcome Measures
Name Time Method Change of liver stiffness 12 months Liver stiffness measured in kilopascals (kPa) by transient elastography at baseline and after intervention.
Anthropometry (height) 12 months Measurement of body height measured in metres (m) to calculate Body Mass Index (BMI).
Change of liver steatosis 12 months Continuous attenuation parameter measured in decibels per meter (dB/m) at baseline and after intervention.
Liver functional tests 12 months 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)Anthropometry (BMI) 12 months Change in BMI from baseline (measured in kg/m\^2).
Lipidogram 12 months Change in cholesterol, LDL cholesterol, HDL cholesterol, triglycerides (measured in mmol/L) from baseline.
Anthropometry (body weight) 12 months Measurement of body weight measured in kilograms (kg) and change from baseline.
Bilirubin level 12 months Change in activity concentration of bilirubin measured in micromoles per liter (umol/L) from baseline.
Trial Locations
- Locations (1)
Central Military Hospital
🇨🇿Prague, Czechia