Type 2 diabetic patients with nonalcoholic fatty liver disease. type 2 diabetes mellitus, nonalcoholic fatty liver disease
Conditions
Interventions
Intervention 1: Control group: Treatment with metformin according to standard instructions and methods. Intervention 2: Intervention group: Treatment with Empagliflozin 25 mg once in the morning added
Sponsors
Oroumia University of Medical Sciences
Eligibility
Sex/Gender
All
Age
20 Years to 75 Years
Inclusion criteria
Inclusion criteria: Controlled type 2 Diabetes Mellitus (T2DM) with HbA1C=6.5-10 BMI greater than 20, with the last 3 months loss of weight below 10% treatment with Metformin, 1500mg daily, at least 3 months as monotherapy Statin consumption Definitive diagnosis of NAFLD under the supervision of a Gastroenterology subspecialty at least grade 1 of non-alcoholic fatty liver disease (NAFLD) based on ultrasonography
Exclusion criteria
Exclusion criteria: Type 1 Diabetes Mellitus (T1DM) Treated with other diabetes medications except for metformin at baseline History of pancreatitis or pancreas related diseases At the beginning of the study ALT more than twice normal upper limits eGFR lower than 45 ml/min Decompensated or untreated Heart Failure (functional class 3 or 4) Other liver diseases include autoimmune hepatitis and viral hepatitis Alcohol consumption more than 140 cc for women and 250 cc for men per week A pregnant woman or someone who is planning a pregnancy breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CAP score or STAGE determination index of steatohepatitis that is measured and evaluated by Fibroscan. Timepoint: at the beginning and the end of study of(after 6 months of treatment). Method of measurement: Fibroscan device and its analysis by an experienced unit. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactLaya Hooshmand Qarehbagh
Oroumia University of Medical Sciences
Outcome results
None listed