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IRCT20190701044062N4 IRCT 2021-01-19 Tabriz University of Medical Sciences Comparison of the therapeutic effect of empagliflozin with pioglitazone and vitamin E on non-alcoholic fatty liver in patients with type 2 diabetes Comparison of the therapeutic effect of empagliflozin with pioglitazone and vitamin E on non-alcoholic fatty liver in patients with type 2 diabetes 2020-11-23 anticipated 66 Complete https://irct.ir/trial/48468 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly divided into control and intervention groups (1: 1). Patients will be assigned to two groups using the randomized block method. Patients will be divided into two equal groups using a random number table. STATA software will be used to generate a random sequence. 3 Non. Intervention 1: Intervention group: Patients will receive daily empagliflozin10 mg and metformin daily for 12 weeks. Intervention 2: Control group: Patients will receive daily pioglitazone 30 mg, vit E and metformin for 12 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is All authors are required to publish the consent and no further information is available
public Manouchehr Khoshbaten
Golgasht Street
Tabriz Iran (Islamic Republic of) 5154751637 +98 41 3337 2088 mkhoshbaten@yahoo.com Tabriz University of Medical Sciences scientific Manouchehr Khoshbaten
Golgasht Street
Tabriz Iran (Islamic Republic of) 5154751637 +98 41 1334 3010 mkhoshbaten@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) 18 to 75 years old BMI <45 kg/m2 A known case of type 2 diabetes used by metformin A known case of non-alcoholic fatty liver HbA1c 6–8% 18 years 75 years Both History of hypoglycemia liver disease Other than non-alcoholic fatty liver Previous use of thiazolidinedione treatment،, immunomodulatory, antiobesity, anti-NASH glucagon-like peptide 1 agonists, sodium–glucose cotransporter 2 inhibitors, or vitamin E, amiodarone, tamoxifen, methotrexate In the last six months severe heart, lung and kidney disease Contraindications to the use of empagliflozin (drug allergy, recurrence of genital urinary tract infection, history of recent or previous gangrene) Uncontrolled type 2 diabetes Changes in diet and activity during the study K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Treatment - Drugs Intervention group: Patients will receive daily empagliflozin10 mg and metformin daily for 12 weeks. Control group: Patients will receive daily pioglitazone 30 mg, vit E and metformin for 12 weeks. Liver enzymes levels before and after vitamin E and pioglitazone administration. Timepoint: At baseline and 3 months after the intervention. Method of measurement: Laboratory methods. Ultrasound grade determination before and after vitamin E and pioglitazone administration. Timepoint: At baseline and 3 months after the intervention. Method of measurement: liver ultrasonography. Liver enzymes levels before and after empagliflozin. Timepoint: At baseline and 3 months after the intervention. Method of measurement: Laboratory methods. Ultrasound grade determination before and after empagliflozin administration. Timepoint: At baseline and 3 months after the intervention. Method of measurement: liver ultrasonography. Tabriz University of Medical Sciences Approved 2020-11-22 Ethics committee of Tabriz University of Medical Sciences Central Office of Tabriz University of Medical Sciences Tabriz, Golghast Street Tabriz East Azarbaijan Iran (Islamic Republic of)