]>
IRCT20170609034406N14 IRCT 2025-12-05 Tabriz University of Medical Sciences Empagliflozin and dapagliflozin in liver transplantation Investigating the effects of empagliflozin and dapagliflozin in patients recently undergone liver transplantation: A randomized double-blind placebo controlled trial 2025-05-21 anticipated 150 Complete https://irct.ir/trial/83081 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Health service research, Randomization description: Randomization will be carried out using random allocation site (https://www.sealedenvelope.com/simple-randomiser/v1/lists) by blocked randomization method with random block size 6 and 9, Blinding description: Participants and health care providers are not aware of the type of grouping of patients, and the study drug will be unrecognizable to patients and related treatment staff. A matched placebo is identical to colchicine in every aspect, such as appearance, smell, and taste. The only person who will know the type of drug is the coordinator of the study. 3 liver transplantation. Intervention 1: Intervention group: Intervention group: Patients will receive 10mg (Gloripa) of empagliflozin oral once daily for six months with standard treatments. Intervention 2: Intervention group: Intervention group: Patients will receive 10mg of dapagliflozin (gloxiga) oral once daily for six months with standard treatments. Intervention 3: Control group: Patients will receive placebo daily for six months with standard treatments. Yes - There is a plan to make this available What will be shared: All of the data of an article can be published after making patients unrecognized. When: After publishing of article until 6 months after publishing of the results To whom: Data will be available to researchers working in academic and scientific institutions. Conditions: Researchers that request data will be permitted only to doing analysis according to ethics for scientific aims. Where to obtain: Applicants can receive data by sending an E-mail to address of anqarekhani@yahoo.com and get response from Dr. Afshin Gharekhani How to obtain: After contacting with corresponding author(Dr. Afshin Gharekhani), data will be sent to Tabriz Imam Reza hospital ethics committee and after receiving permission, data will be send to applicants Comments:
public Dr Afshin Gharekhani
Imam Reaza Center, Parastar Street,Tabriz
Tabriz Iran (Islamic Republic of) 5166414766 +98 914 103 2283 anqarekhani@yahoo.com Tabriz University of Medical Sciences scientific Dr Afshin Gharekhani
Faculty of Pharmacy, Daneshghah Street,Tabriz
Tabriz Iran (Islamic Republic of) 5166414766 +98 914 103 2283 anqarekhani@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) patients with liver transplantation aged 18 to 80 consented patients 18 years 80 years Both Pregnancy Lactation kidney failure heart failure contraindications of empagliflozin or dapagliflozin systolic blood pressure less than 100 or more than 180 mm Hg Autoinflammatory diseases Malignancy Diabetes mellitus Z94.4 Liver transplant status Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Intervention group: Patients will receive 10mg (Gloripa) of empagliflozin oral once daily for six months with standard treatments Intervention group: Intervention group: Patients will receive 10mg of dapagliflozin (gloxiga) oral once daily for six months with standard treatments. Control group: Patients will receive placebo daily for six months with standard treatments Acute organ rejection. Timepoint: before intervention, second week,4th week, 8th week, 12th week and 16th week after intervention. Method of measurement: biopsy. Survival of transplanted tissue. Timepoint: at baseline, the third month and the sixth month after the intervention. Method of measurement: clinical assessment. Effect of empagliflozin and dapagliflozin on the incidence of new diabetes mellitus following liver transplantation. Timepoint: at baseline, the third month and the sixth month after the intervention. Method of measurement: Measurement of hemoglobin A1C, fasting blood sugar and two-hour blood sugar. Tabriz University of Medical Sciences Approved 2025-03-03 Ethics Committee of Tabriz University of Medical Sciences Research & Technology Dept, Central Building No. 2, Third Floor, Tabriz University of Medical Sciences, Golghast St, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)