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IRCT20210609051526N2 IRCT 2021-09-15 Babol University of Medical Sciences Effect of Empagliflozin in diabetic patients with non-alcoholic steatohepatitis Effect of Empagliflozin on Liver Enzymes level in type two Diabetic Patients with Non-Alcoholic Steatohepatitis 2021-09-23 anticipated 110 Complete https://irct.ir/trial/58623 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: We will assign each person to one of the two study groups in a one-to-one ratio using the random block method. Using the site www.sealedenvelope.com, with seed number 186476011923636 and block size 4 and the length of the list 110 and the code specific to each person, we made a random list, which we gave to a member of the research team who has no role in patient recruitment and data analysis. The person in charge of patients recruitment will call the person who has a random list and receive a code specific to the patient and assign it to the patient. The treatment protocol will be performed based on the code assigned to The patient. The person in charge of the patient's follow-up and data analysis will not be aware of the treatment protocol used for that person, Blinding description: The participant will be kept blind from receiving a drug or placebo by using a placebo with the same shape, color, and size as the drug. The clinician only knows the code assigned to the patient and does not know the patient's treatment. Only one researcher from the research team, who has no role in patient recruitment and data analysis, has access to the randomization list containing each individual's specific code and treatment protocol and does not reveal it to anyone except in life-threatening cases or based on the decision of the university ethics committee. The outcome assessor only has access to the code assigned to the patient and does not know the treatment protocol of that code. The data analyzer does not know each patient's treatment protocol, and we will provide the coded data to him. 3 non-alcoholic steatohepatitis. Intervention 1: Intervention group: Standard treatment for type 2 diabetes with one 10 mg Empagliflozin tablet daily. Intervention 2: Control group: Standard treatment for type 2 diabetes with one placebo tablet daily. Yes - There is a plan to make this available What will be shared: We can share the collected data with unidentified individuals. When: Six months after, we can share the publication of the article extracted from the data plan. To whom: Researchers working in academic institutions Conditions: The researcher announces his proposal and the required data to the project manager to provide the data to him if possible. Where to obtain: The person responsible for the scientific responsibility of the trial How to obtain: The researcher should send the request to the email of the person responsible for the scientific responsibility of the project. Comments:
public Neda Meftah
Ayatollah Rouhani Hospital, Daneshgah Square, Ganjafrooz Avenue
Babol Iran (Islamic Republic of) 47176-41367 +98 11 3233 8301 n.meftah@mubabol.ac.ir Babol University of Medical Sciences scientific Neda Meftah
Ayatollah Rouhani Hospital, Daneshgah Square, Ganjafrooz Avenue
Babol Iran (Islamic Republic of) 47176-41367 +98 11 3233 8301 n.meftah@mubabol.ac.ir Babol University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Body mass index less than 35 Kg/mm No history of chronic alcohol usage No history of viral hepatities No history of autoimmune hepatitis No history of drug-induced hepatitis No history of chronic usage of hepatic-steatosis-induced drugs(e.g.: Amiodarone, Valproate, Tamoxifen, Methotrexate, Glucocorticoids) No history of chronic usage of Thiazolidines and GLP-1 agonists Absence of evidence suggestive for cirrhosis based on physical examination, laboratory evaluation, and imaging studies Absence of evidence suggestive for Hepatocellular carcinoma based on physical examination, laboratory evaluation, and imaging studies Non pregnant women No previous history of HELLP syndrome in women No history of chronic kidney disease No history of chronic usage of Omega-3 containing supplements No contraindication for Empagliflozin usage (e.g.: history of recurrent genitourinary tract infection, gangrene, history of allergic reaction to the drug, serum Trigliceride level more than 500 mg/dl) 18 years 85 years Both K75.81 Nonalcoholic steatohepatitis (NASH) Treatment - Drugs Placebo Intervention group: Standard treatment for type 2 diabetes with one 10 mg Empagliflozin tablet daily Control group: Standard treatment for type 2 diabetes with one placebo tablet daily Aspartate transaminase. Timepoint: Before the start of the study, 12 and 24 weeks after the start of treatment. Method of measurement: Serum level measurement. Alanine transaminase. Timepoint: Before the start of the study, 12 and 24 weeks after the start of treatment. Method of measurement: Serum level measurement. Alkaline phosphatase. Timepoint: Before the start of the study, 12 and 24 weeks after the start of treatment. Method of measurement: Serum level measurement. Body weight. Timepoint: Before the start of the study, 12 and 24 weeks after the start of treatment. Method of measurement: Using scales and in kilograms. Weight cirmucfrences. Timepoint: Before the start of the study, 12 and 24 weeks after the start of treatment. Method of measurement: Using meters and in centimeters. Babol University of Medical Sciences Approved 2021-08-31 Ethics committee of Babol University of Medical Sciences Babol University of Medical Sciences, Ganjafrooz Street, Babol, Mazandaran, Iran Babol Mazandaran Iran (Islamic Republic of)