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IRCT20220928056051N1 IRCT 2022-10-04 Oroumia University of Medical Sciences Comparing the effect of Empagliflozin with Pioglitazone on nonalcoholic fatty liver Comparing the effect of Empagliflozin with Pioglitazone on nonalcoholic fatty liver in diabetic type 2 patients treated with metformin 2022-07-14 anticipated 60 Complete https://irct.ir/trial/66148 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be divided into two groups using the block randomization method based on generated numbers by Random allocation software. Thus, in this software, first, the number of groups and the total determined sample size will be entered, and then in the block section, the Block randomization method will be implemented. According to the total sample size (60 patients), 15 blocks of 4 will be used. Patients will be allocated to intervention groups based on generated numbers. 3 Non-alcoholic fatty liver disease. Intervention 1: Intervention group: In group one, patients will receive 30 mg pioglitazone daily in addition to the standard treatment (metformin) for 6 months. Intervention 2: Intervention group: in group two, patients will receive 10 mg empagliflozin daily in addition to the standard treatment (metformin) for 6 months. No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidentiality of patient information
public Dr. Laya Hooshmand
Ershad Ave., Modarress Blvd., Imam Khomeini hospital., Urmia., Iran.
Urmia Iran (Islamic Republic of) 57157-89397 +98 44 3245 7286 hooshmand.l@umsu.ac.ir Oroumia University of Medical Sciences scientific Dr. Laya Hooshmand
Ershad Ave., Modarress Blvd., Imam Khomeini hospital., Urmia., Iran.
Urmia Iran (Islamic Republic of) 57157-89397 +98 44 3345 7286 hooshmand.l@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) Age between 20 to 75 years Type 2 diabetes A hemoglobin A1C (HbA1c) between 7 and 10 Body mass index (BMI) between 20 to 40 kg/m2 Treated with metformin for at least three months with a minimum dose of 1500 mg daily َAt least grade 1 of non-alcoholic fatty liver disease (NAFLD) 20 years 75 years Both Patients receiving drugs that stimulate insulin secretion, or insulin Type 1 diabetes Patients treated with diabetes drugs including sitagliptin and liraglutide Glomerular Filtration Rate (GFR) less than 30 Uncontrolled or aggravated heart disease (class 3 and 4) Liver diseases including autoimmune hepatitis and viral hepatitis Alcohol consumption of more than 140 cc for women and 250 cc for men per week Pregnancy breastfeeding History of recurrent urinary tract infection Bladder Cancer K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Treatment - Drugs Intervention group: In group one, patients will receive 30 mg pioglitazone daily in addition to the standard treatment (metformin) for 6 months. Intervention group: in group two, patients will receive 10 mg empagliflozin daily in addition to the standard treatment (metformin) for 6 months. Liver steatosis score. Timepoint: Before and 6 months after the intervention. Method of measurement: Fibroscan. Alanine transaminase (ALT). Timepoint: Before and 6 months after the intervention. Method of measurement: blood sample. Aspartate transaminase (AST). Timepoint: Before and 6 months after the intervention. Method of measurement: blood sample. Alkaline phosphatase (ALKP). Timepoint: Before and 6 months after the intervention. Method of measurement: blood sample. HbA۱c. Timepoint: Before and 6 months after the intervention. Method of measurement: Blood sample. Cholesterol. Timepoint: Before and 6 months after the intervention. Method of measurement: Blood sample. High-density lipoprotein (HDL). Timepoint: Before and 6 months after the intervention. Method of measurement: Blood sample. Low-density lipoprotein (LDL). Timepoint: Before and 6 months after the intervention. Method of measurement: Blood sample. Triglyceride. Timepoint: Before and 6 months after the intervention. Method of measurement: Blood sample. Serum creatinine. Timepoint: Before and 6 months after the intervention. Method of measurement: Blood sample. Glomerular filtration rate (GFR). Timepoint: Before and 6 months after the intervention. Method of measurement: Based on the formula. Serum insulin. Timepoint: Before and 6 months after the intervention. Method of measurement: Blood sample. Oroumia University of Medical Sciences Approved 2022-07-13 Ethics Committee of Urmia University of Medical Sciences Urmia University of Medical Sciences, Resalat Ave, Jahad Blvd., Urmia, Iran. Urmia West Azarbaijan Iran (Islamic Republic of)