Evaluation of dapagliflozin effects on non-diabetic non-alcoholic fatty liver treatment

Investigating the effect of dapagliflozin on patients with non-alcoholic fatty liver disease

Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 110 patients. For randomization, the table of random numbers was used using the website www.randomization.com.

This study is conducted on patients with non-alcoholic fatty liver disease who have referred to the liver clinic or endocrinology and metabolism outpatient clinic of Qaem Hospital located in Mashhad, Iran.For sampling, the envelope method is used:The envelopes will be prepared by a member of the research team and random numbers with the help of Randomaize.com and placed inside the envelope. The lid of the envelopes will be closed and its contents will not be visible from the outside. Then, first, the purpose of the study is explained to the person who meets the stated conditions, and if the person wishes, he signs the informed consent form and takes an envelope, then opens it, and based on the contents of the envelope, the person is entered into the intervention or control group.The analyst and the therapist do not know the type of treatment

Healthy subjects from general population aged between 20 and 65 years who have a controlled attenuation parameter (CAP) greater than or equal to 238dB/m on liver fiber scan will be included in the study.The exclusion criteria are hepatic and non-hepatic diseases, or the use of drugs that cause fatty liver, or treatment with other drugs that affect fatty liver.

Patients in the intervention group will be given dapagliflozin 10 mg daily for three months

FBS, Chol, TG, LDL, HDL, AST, ALT performing fibroscan to determine the amount of liver fat in all patients at the beginning of the study and 3 months after the onset treatment

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.

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.