]>
IRCT20230903059343N1 IRCT 2023-10-04 Arak University of Medical Sciences Comparing the effect of Empagliflozin, Pioglitazone and their combination, on the course of non-alcoholic fatty liver disease in diabetic patients Comparing the effect of Empagliflozin, Pioglitazone and their combination, on sonographic and biochemical features of non-alcoholic fatty liver disease in diabetic patients 2023-10-16 anticipated 120 Complete https://irct.ir/trial/72608 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will not be aware of the pattern of drug allocation for other patients. The patients will be visited by the physician, then go to one of the collaborators of the study to recieve their drugs. The collaborator will have no role in the treatment of the patients or analysis of the data. Each patient is placed in one of the groups based on the "permutation randomization block" method and recieve the corresponding drug box. In this study, the "permutation randomization block" method will be used for randomization with 6-ply blocks. In each block, each of the the following letters will be written on three cards: letter "E" (Empagloflozin), letter "P" (Pioglitazone) and letter "D" (Dual). The randomized 6-letter blocks will be PDPEED،DPDPEE ، EDPDPE، EEDPDP، PEEDPD، PPDPDEE،EDPPED ،PDPEPDE ،PDPEDE ، DPEEPD، PDEEPD،DPPEED ، PDEPDE، PPDDEE،DPEDEP ، DEPEPD ، DPPEDE، EPPDPDE، EPDPEPD، DEPDPEP. For example, the random allocation in the PDPEED block will be: The first patient allocated to D, the second to E, the third to E, the fourth to P, the fifth to D, and the sixth patient allocated to P. 2-3 Non-alcoholic fatty liver disease. Intervention 1: Intervention group: Recipients of Empagliflozin 10mg daily for 6 months. Intervention 2: Intervention group: Recipients of Pioglitazone 15 mg daily for 6 months. Intervention 3: Intervention group: Recipients of Empagliflozin 10 mg+ Pioglitazone 15 mg daily for 6 months. 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 No decision regarding the publishing of this study has been taken due to the fact that the study is not finished.
public Dr Erfan Rezaeisafa
Arak University of Medical Sciences, Sardasht, Arak
Arak Iran (Islamic Republic of) 3848176341 +98 86 3417 3639 Sorbsorbian@gmail.com Arak University of Medical Sciences scientific Dr Erfan Rezaeisafa
Arak University of Medical Sciences, Sardasht, Arak
Arak Iran (Islamic Republic of) 3848176341 +98 86 3417 3639 Sorbsorbian@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) All patients with type 2 diabetes phenotype and fatty liver disease 20 years 65 years Both History of alcohol ingestion Cirrhosis Heart failure, NYHA class III or IV Chronic kidney disease with GFR<45 ml/min Other chronic liver diseases including viral or autoimmune hepatitis Current use of Empagliflozine or Pioglitazone Use of known causative drugs for fatty liver including NSAIDs, Tamoxifen, Amiodarone and Valproate Use of antioxidant agents during the past 3 months, including Vitamin C, Zinc or Selenium-containing supplements. HbA1c less than 7 or more than 9 percent Type 1 diabetes or diabetes due to a specific secondary cause Pregnancy or Lactation Active cancer during the last two years Cardiovascular events during the last 3 months History of hypothyroidism Wilson's disease BMI>40 kg/m2 History of biliary obstruction Glucocorticoid use for 2 weeks during the last 2 months K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Recipients of Empagliflozin 10mg daily for 6 months. Intervention group: Recipients of Pioglitazone 15 mg daily for 6 months. Intervention group: Recipients of Empagliflozin 10 mg+ Pioglitazone 15 mg daily for 6 months. The proportion of patients in Empagliflozin treatment group who achieve meaningful (at least one grade) decrease in sonographic grade of their fatty liver disease. Timepoint: At the start of the study, then 6 months later. Method of measurement: Sonography equipment. The proportion of patients in Pioglitazone treatment group who achieve meaningful (at least one grade) decrease in sonographic grade of their fatty liver disease. Timepoint: At the start of the study, then 6 months later. Method of measurement: Sonography equipment. The proportion of patients in Empagliflozin plus Pioglitazone treatment group who achieve meaningful (at least one grade) decrease in sonographic grade of their fatty liver disease. Timepoint: At the start of the study, then 6 months later. Method of measurement: Sonography equipment. The mean change in sonographic grade in Empagliflozin group. Timepoint: At the start of the study, then 6 months later. Method of measurement: Sonography equipment. The mean change in sonographic grade in Pioglitazone group. Timepoint: At the start of the study, then 6 months later. Method of measurement: Sonography equipment. The mean change in sonographic grade in ٍEmpagliflozin plus Pioglitazone group. Timepoint: At the start of the study, then 6 months later. Method of measurement: Sonography equipment. The mean change of APRI (AST to Platelet Ratio Index) score in Empagliflozin group. Timepoint: At the start of the study, then 6 months later. Method of measurement: Specific laboratory kit for Aspartate aminotransferase and Platelets, then using APRI formula. The mean change of APRI (AST to Platelet Ratio Index) score in Pioglitazone group. Timepoint: At the start of the study, then 6 months later. Method of measurement: Specific laboratory kit for Aspartate aminotransferase and Platelets, then using APRI formula. The mean change of APRI (AST to Platelet Ratio Index) score in Empagliflozin plus Pioglitazone group. Timepoint: At the start of the study, then 6 months later. Method of measurement: Specific laboratory kit for Aspartate aminotransferase and Platelets, then using APRI formula. The mean change in FIB-4 score in ٍEmpagliflozin group. Timepoint: At the start of the study, then 6 months later. Method of measurement: Specific laboratory kit for Aspartate aminotransferase and Platelets, then using FIB-4 formula. The mean change of FIB-4 score in Pioglitazone group. Timepoint: At the start of the study, then 6 months later. Method of measurement: Specific laboratory kit for Aspartate aminotransferase and Platelets, then using FIB-4 formula. The mean change of FIB-4 score in ٍEmpagliflozin plus Pioglitazone group. Timepoint: At the start of the study, then 6 months later. Method of measurement: Specific laboratory kit for Aspartate aminotransferase and Platelets, then using FIB-4 formula. Arak University of Medical Sciences Approved 2023-07-04 Research ethics committee of Arak University of Medical Sciences Arak University of Medical Sciences, Arak Arak Markazi Iran (Islamic Republic of)