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IRCT20220115053717N1 IRCT 2022-06-17 Oroumia University of Medical Sciences Investigating the Empagliflozin effect on nonalcoholic fatty liver in patients with diabetic type 2 with metformin-containing regimens The comparison of the Empagliflozin effect on nonalcoholic fatty liver in patients with diabetic type 2 with metformin-containing regimens 2022-06-19 anticipated 60 Complete https://irct.ir/trial/63339 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be divided into intervention or control 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 (60 patients), and then in the block section, the Block randomization method will be implemented. Patients will be allocated to groups based on generated numbers. Random Allocation Software version 1.0.0 has been developed by Mr. Saghaei, MD. department of anesthesia, Isfahan University of Medical Sciences, Isfahan, Iran. 2-3 Type 2 diabetic patients with nonalcoholic fatty liver disease. 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 to the standard treatment (Metformin). Yes - There is a plan to make this available What will be shared: The data that support the findings of this study are available from the corresponding author, L. H., upon reasonable request. When: The data that support the findings of this study are available from the corresponding author, L. H., upon reasonable request. To whom: The data that support the findings of this study are available from the corresponding author, L. H., upon reasonable request. Conditions: The data that support the findings of this study are available from the corresponding author, L. H., upon reasonable request. Where to obtain: The data that support the findings of this study are available from the corresponding author, L. H., upon reasonable request. How to obtain: The data that support the findings of this study are available from the corresponding author, L. H., upon reasonable request. Comments:
public Laya Hooshmand Qarehbagh
Imam Khomeini University Hospital, Ershad St.
Urmia Iran (Islamic Republic of) 5715781351 +98 44 3346 9931 laya.hooshmand58@gmail.com Oroumia University of Medical Sciences scientific Laya Hooshmand Qarehbagh
Imam Khomeini University Hospital, Ershad St.
Urmia Iran (Islamic Republic of) 5715781351 +98 44 3346 9931 laya.hooshmand58@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) 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 20 years 75 years Both 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 5A11, DB92 type 2 diabetes mellitus, nonalcoholic fatty liver disease Treatment - Drugs Treatment - Drugs Control group: Treatment with metformin according to standard instructions and methods Intervention group: Treatment with Empagliflozin 25 mg once in the morning added to the standard treatment (Metformin) 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. Oroumia University of Medical Sciences Approved 2022-01-02 Ethics Committees of Urmia University of Medical Sciences Orjhans Street, Resalat Blvd, Urmia Urmia West Azarbaijan Iran (Islamic Republic of)