Effect of Empagliflozin on Liver Fat in Non-diabetic Patients

Launched by THE UNIVERSITY OF HONG KONG · Nov 21, 2020

Keywords

ClinConnect Summary

Non-alcoholic fatty liver disease (NAFLD) is a global epidemic with a prevalence of 25%. Currently therapies for NAFLD patients without diabetes mellitus (DM) are limited, and are associated with various adverse side effects. Sodium-glucose cotransporter type-2 (SGLT2) inhibitors are antidiabetic drugs that reduce hepatic fat content in patients with DM, which is independent of glycemic control. However, the role of SGLT2 inhibitors in NAFLD patients without DM has not been investigated. Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) is an emerging non-invasive im...

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Eligibility criteria

• Inclusion Criteria:
• • Potential study subjects will first be screened by transient elastography for the presence of hepatic steatosis (defined as a measurement of controlled attenuation parameter \[CAP\] \>= 248 db/M).
• • They will be recruited into study if steatosis is \>= 5% as confirmed by MRI-PDFF
• Exclusion Criteria:
• • DM (defined as hemoglobin A1c \[HbA1c\] \>= 6.5% or fasting glucose \>= 7.0 mmol/L)
• • alcohol intake \> 20g within past 2 years
• • concurrent chronic liver diseases (including chronic viral hepatitis infection, autoimmune hepatitis, Wilson's disease, hemochromatosis, congestive hepatopathy, primary biliary cholangitis, primary sclerosing cholangitis, biliary tract obstruction)
• • drug-induced liver disease
• • usage of drugs that can lead to hepatic steatosis (e.g. steroids, amiodarone, valproate, methotrexate, tamoxifen)
• • decompensated cirrhosis (including ascites, hepatic hydrothorax, variceal bleeding, hepatic encephalopathy, hepatorenal syndrome, hepatopulmonary syndrome)
• • history of malignancy including HCC
• • recreational substance abuse
• • pregnancy
• • contraindications to empagliflozin use (estimated glomerular filtration rate \[eGFR\] \<45mL/min/1.73m2 as measured by the MDRD equation, history of recurrent genitourinary tract infections, gangrene, or allergy)
• • contraindications to MRI (e.g., claustrophobia, certain cardiac pacemakers, implanted medical devices with ferromagnetic properties).