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IRCT20230315057726N1 IRCT 2023-08-26 Islamic Azad University Comparing the effectiveness of Empagliflozin with Metformin in controlling Diabetes Mellitus in patients with post-organ transplant diabetes Comparing the effectiveness ofEmpagliflozin with Metformin in controlling Diabetes Mellitus in patients with post-organ transplant diabetes 2023-08-01 anticipated 40 Complete https://irct.ir/trial/70948 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization Individual Sealed envelopes As the numbers of each envelope are finished, the next envelope will be opened until the sample is completed. The principal investigator and the patient are unaware of the contents of the envelopes. Only the pharmacist who delivers the medicine; knows the type of medicine. The pharmacist delivers both types of medicine to the patient in capsules with the same appearance, Blinding description: We will use block randomization to allocate the samples to intervention and control groups. For this purpose, we prepare four sheets of paper. On two sheets, we write the letter a for the treatment group of empagliflozin. Then on the other two sheets, we write the letter b for the treatment group of metformin. We mix the sheets together and put 4 sheets (two sheets with the letter A and two sheets with the letter B) in the sealed envelope. With the referral of each qualified patient, one of the sheets will be randomly drawn, and based on this drawn sheet, whether it is a or b, they will be assigned to one of the above-mentioned two groups. It should be noted that we will not refer to the next envelope until all four sheets have been pulled out. After randomly pulling out all four sheets, we go to the next sealed envelope and repeat the above procedure for the next four patients until we reach the desired sample size. The main researcher and the patient are unaware of the contents of the envelopes. Only the pharmacist who delivers the medicine knows the type of medicine. The pharmacist delivers both types of medicine to the patient in capsules with the same appearance. 3 Post Transplant Diabetes Mellitus. Intervention 1: Intervention group A: Empagliflozin 10mg(َIran, Tehran, Abidi Pharmaceutical Company) for 3 months. Intervention 2: Intervention groupB: Metformin 500 mg(َIran, Alborz, Actoverco Pharmaceutical Company ) for 3 months. Yes - There is a plan to make this available What will be shared: All project implementers have access to the data When: whole study time To whom: All project implementers Conditions: The data is published together and without mentioning the name Where to obtain: The chief investigator Dr. Maryam Vasheghani mvasheghani9@sbmu.ac.ir Amirhossein Niknejad amirhosseinniknejad@gmail.com How to obtain: The applicants must send their request via E-Mail to the aforementioned researchers, and after the review and approval of the ethics committee of Islamic Azad University of Medical Sciences, the information will be provided to the applicant to the extent necessary without mentioning the names of patients. Comments: The data is published together and without mentioning the name
public Amirhossein niknejad
No. 6, Ravanpour St., Jordan Blvd., Tehran
Tehran Iran (Islamic Republic of) 1966874513 +98 21 2202 3410 amirhosseinniknejad@gmail.com Islamic Azad University scientific Maryam Vasheghani
Darabad, Niavaran
Tehran Iran (Islamic Republic of) 1956944413 +98 21 2712 2020 mvasheghani9@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) At least 6 months have passed since the patient's transplant No previous history of diabetes and use of any blood sugar-lowering medication Diagnosing diabetes according to the criteria of the American Diabetes Association HbA1c< 8% HbA1c>6.5% 18 years no limit Both Rejection of the transplanted organ in the patient Transplanted organ failure Pregnancy Age less than 18 years Any contraindication related to empagliflozin (allergy to the drug or its components, dialysis, diabetic ketoacidosis, hospitalization) The patient's unwillingness to participate in the study BMI above 40 Severe liver failure (enzymes more than 3 times the normal limit) or renal failure (creatinine more than 2), creatinine clearance below 60 Any contraindication related to Metformin (allergy to the drug or its components, dialysis, diabetic ketoacidosis, hospitalization) E13 Other specified diabetes mellitus Treatment - Drugs Treatment - Drugs Intervention group A: Empagliflozin 10mg(َIran, Tehran, Abidi Pharmaceutical Company) for 3 months. Intervention groupB: Metformin 500 mg(َIran, Alborz, Actoverco Pharmaceutical Company ) for 3 months. HbA1c. Timepoint: To compare the effectiveness of two drugs, empagliflozin and metformin, HbA1C of patients with Post Transplant Diabetes Mellitus(PTDM) is measured at the beginning of the study and 90 days after taking the drug. Method of measurement: Blood Sample. FBS (fasting blood sugar). Timepoint: To compare the effectiveness of two drugs, empagliflozin and metformin, FBS of patients with Post Transplant Diabetes Mellitus(PTDM) is measured at the beginning of the study and 90 days after taking the drug. Method of measurement: Blood Sample. Islamic Azad University Approved 2023-01-02 Research Ethics Committees of Islamic Azad Tehran Medical Sciences University - Pharmacy and Pharmac School of Pharmacy and Pharmaceutical Sciences - Islamic Azad University of Medical Sciences, Tehran (Research Ethics Committee), yakhchal, Qolhak, Shariati Tehran Tehran Iran (Islamic Republic of)