Effect of Erugliflozin On Liver Fat, Liver Fibrosis and Glycemic Control in Type II DM Patients With NASH/NAFLD (Ertu-NASH)
Liver Fat, Liver Fibrosis, Glycemic Control
About this trial
This is an interventional treatment trial for Liver Fat
Eligibility Criteria
Inclusion Criteria: Patient able to provide written informed consent Adult males & females between 18 to 65 years SGLT2i and insulin naïve patients BMI >23 Kg/m2 HbA1C % ≥ 6.5 to 10 Documented hepatic steatosis or fatty liver disease on Ultrasound Patient with Type II Diabetes Mellitus Exclusion Criteria: History of use of SGLT 2 inhibitors or Glucagon-like peptide (GLP) 1 agonist or insulin; 3 months prior to enrollment in the study. Pioglitazone use in the past 6 months History of vitamin E use (400mg twice daily) 3 months prior to enrollment in the study. History of anti-obesity medication or weight loss procedure (bariatric surgery) use within 3 months prior to enrollment in the study. History of uncontrolled Endocrine disorder (for example uncontrolled hypothyroidism, or that requires frequent dose adjustment, or Cushing's syndrome) History of liver disease including viral hepatitis, auto-immune hepatitis, liver cirrhosis, hepatocellular carcinoma and/or HIV History of recurrent UTIs and mycotic infection. Severely ill patients (who have high grade fever, sepsis or acute infection) Pregnant woman, lactating woman or planning pregnancy during study duration History of Drug-induced liver disease (e.g. amiodarone, valproate, tamoxifen, methotrexate, steroids (including homeopathic medicines). History of active substance abuse (cannabinoid-derived substances like heroin, cocaine, amphetamines) based on history and/or laboratory tests Alcohol intake 10 - 30 g/day (three drinks per day) within the previous year Active substance abuse such as acetaminophen over-use, hashish, tobacco products, heroin, cocaine or amphetamines. Severe hepatic impairment ( AST & ALT levels > 3 times upper limit normal
Sites / Locations
Arms of the Study
Arm 1
Experimental
Ertugliflozin
Ertugliflozin 5/15mg once daily with standard of care