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IRCT20110727007134N2 IRCT 2025-01-25 Mashhad University of Medical Sciences effects of Dapaglifozin on non-alcoholic fatty liver disease Evaluation of dapagliflozin effects on non-diabetic non-alcoholic fatty liver treatment 2025-01-20 anticipated 110 Complete https://irct.ir/trial/81063 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random assignment of people to study groups while ensuring the equality of the sample size of the groups, the block method will be used as a reliable method of randomization that leads to the balanced allocation of people in treatment groups at the end of each block. For this purpose, we use the site: https://www.sealedenvelope.com/simple-randomiser/v1/lists. In this study, the size of the blocks is 6 and 8 and a total of 16 blocks consisting of 8 blocks of 6 and 8 blocks of 8 with different sequences are formed from both arms of the study at the output of the site.Next, each of the blocks is sealed in a non-transparent sealed envelope and all the blocks are randomly arranged. With the referral of each eligible patient, the first block is randomly selected and depending on the order of the sequence, the desired person is placed in one of the arms of the study.In the same way, after the completion of the first block, the second block is randomly selected and this continues until the last block and assigning the last person to the study arms. As a rule, by assigning the last sheet of the last block, the patients are grouped equally in the two arms of the study and the balance between the groups is established, Blinding description: Due to the fact that the intervention and placebo drugs are prepared in similar packages in terms of appearance, size, and color, the patient will not be informed in which group he is placed. Also, the person evaluating the results will not be informed about the type of drug the patient is taking. 3 fatty liver. Intervention 1: Intervention group: Intervention group: they will receive the drug Dapagliflozin 10 mg daily for 90 days, produced by Medava Pharmaceutical Company, Tehran, Iran. Intervention 2: Control group: They will receive the placebo, which is similar in appearance to the pills of the intervention group, for 90 days, produced by Medava Pharmaceutical Company, Tehran, Iran. 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 After the end of the study and before the publication of the results, a decision will be made regarding this isssue
public Zahra Mazloum Khorasani
Ahmad abad street, Qaim hospital
Mashhad Iran (Islamic Republic of) 99199-91766 +98 51 3840 0001 mazloumz@mums.ac.ir Mashhad University of Medical Sciences scientific Zahra Mazloum Khorasani
university campus, Azadi square, Mashhad
mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2000 mazloumz@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Individuals from the general population aged between 20 and 65 years A controlled attenuation parameter (CAP) greater than or equal to 238dB/m in the liver fiber scan test 20 years 65 years Both Known diseases including:Type 1 or 2 diabetes, acute or chronic liver disease, biliary tract disease, kidney or heart failure, active cancer or anticancer treatment within the past two years, untreated thyroid disease History of alcohol consumption drugs related to fatty liver such as continuous and daily use of non-steroidal anti-inflammatory drugs, amiodarone, tamoxifen, sodium valproate, methotrexate and corticosteroids, other drugs that affect fatty liver such as vitamin E and pioglitazone use of supplements such as vitamin C in the last month cardiovascular events in the last three months, pregnancy and breastfeeding, BMI greater than or equal to 40 kg/m2. K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Placebo Intervention group: Intervention group: they will receive the drug Dapagliflozin 10 mg daily for 90 days, produced by Medava Pharmaceutical Company, Tehran, Iran. Control group: They will receive the placebo, which is similar in appearance to the pills of the intervention group, for 90 days, produced by Medava Pharmaceutical Company, Tehran, Iran. Measurement of liver fat using controlled attenuation parameter. Timepoint: At the beginning of the study and after 3 months of treatment with dapagliflozin tablets or placebo. Method of measurement: Using liver fibroscan. Measurement of CBC/diff. Timepoint: At the beginning of the study and 3 months after the start of treatment. Method of measurement: Using laboratory methods. Measurement of ALT,. Timepoint: At the beginning of the study and 3 months after the start of treatment. Method of measurement: Using laboratory methods. Measurement of AST. Timepoint: At the beginning of the study and 3 months after the start of treatment. Method of measurement: Using laboratory methods. Measurement of HDL. Timepoint: At the beginning of the study and 3 months after the start of treatment. Method of measurement: Using laboratory methods. Measurement of LDL. Timepoint: At the beginning of the study and 3 months after the start of treatment. Method of measurement: Using laboratory methods. Measurement of TG. Timepoint: At the beginning of the study and 3 months after the start of treatment. Method of measurement: Using laboratory methods. Measuremnet of Chol. Timepoint: At the beginning of the study and 3 months after the start of treatment. Method of measurement: Using laboratory methods. Measurement of FBS. Timepoint: At the beginning of the study and 3 months after the start of treatment. Method of measurement: Using laboratory methods. Measurement of Controlled attenuation parameter. Timepoint: At the beginning of the study and 3 months after the start of treatment. Method of measurement: Using liver fibroscan. Mashhad University of Medical Sciences Approved 2024-05-28 Ethics Committee of Faculty of Medicine, Mashhad University of Medical Sciences Faculty of Medicine, Mashhad University Of Medical Sciences, Azadi Square, Mashhad, Khorasan Razavi Province, Iran mashhad Razavi Khorasan Iran (Islamic Republic of)