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IRCT20191228045924N7 IRCT 2023-11-12 Mashhad University of Medical Sciences additional effect of methylene blue to empagliflozin on diabetic nephropathy Investigating the additional effect of methylene blue to empagliflozin on nephropathy in patients with type II diabetes 2023-11-21 anticipated 50 Complete https://irct.ir/trial/73484 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This method is used to prevent noticeable imbalances in the number of participants assigned to each group. Randomized blocking ensures that no significant imbalance occurs between groups at any point during randomization, and that the number of participants in each group is equal at specific points. To implement this method, the block size must be determined initially (e.g., a block of four). In order to reduce the predictability of the randomization process, various block sizes are employed in blocked randomization. For this purpose, we consider 10 blocks of four and 5 blocks of two for the 50 patients who are to be included in the study. The list of four-person blocks is created, and numbers from 1 to 6 are assigned to them (AABB(1)- ABAB(2)-ABBA(3)-BBAA(4)- BABA(5)- BAAB(6)). Additionally, the list of two-person blocks consists of AB and BA. Finally, treatment allocation is carried out based on the obtained sequences (..., AABB-BBAA-BABA). 2 Diabetic nephropathy. Intervention 1: Intervention group: The intervention group includes Diabetic patients in whom microalbuminuria has been confirmed, despite standard treatments (Empagliflozin ) , will be undergone oral methylene blue intervention for 6 months. Methylene blue is given to the patient in the form of a sachet to be dissolved in 200 ml of Milk and drunk after one hour. Intervention 2: Control group: This group comprises diabetic patients in whom the presence of microalbuminuria has been confirmed. These patients will receive standard treatment with empagliflozin. Additionally, these patients will be administered 200 milliliters of milk. 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 There is no further information
public Daryoush Hamidi Alamdari
Iman Reza Hospital, Daneshgah Ave
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3882 8574 hamidiad@mums.ac.ir Mashhad University of Medical Sciences scientific Daryoush Hamidi Alamdari
Daneshgah Street, Surgical Oncology Research Center, Mashhad University of Medical Sciences, General Surgery Department, Building No. 2, Imam Reza hospital
mashhad Iran (Islamic Republic of) 9133913716 +98 51 3841 2081 hamidiad@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Individuals diagnosed with type 2 diabetes between the ages of 25 and 65 are eligible for inclusion in the study. Patients with a Glomerular Filtration Rate (GFR) greater than 25 and less than 90 Absence of liver insufficiency or active liver disease Absence of active infection and sepsis. Exclusion of professional athletes and individuals who have not engaged in intense physical exercise in the 9 days leading up to the sample collection. Patients not currently undergoing treatment with insulin. Patients with no history of polycystic kidney disease. Absence of acute kidney failure due to causes other than diabetes, such as infection. No history of cardiovascular diseases No history of uncontrolled high blood pressure. Absence of cancer or any other endocrine diseases. Not having Glucose 6-phosphate dehydrogenase (G6PD) deficiency 25 years 65 years Both Patient's non-consent for continued cooperation. Absence of cancer or any other endocrine diseases. E11.2 Type 2 diabetes mellitus with renal complications Treatment - Drugs Treatment - Drugs Intervention group: The intervention group includes Diabetic patients in whom microalbuminuria has been confirmed, despite standard treatments (Empagliflozin ) , will be undergone oral methylene blue intervention for 6 months. Methylene blue is given to the patient in the form of a sachet to be dissolved in 200 ml of Milk and drunk after one hour. Control group: This group comprises diabetic patients in whom the presence of microalbuminuria has been confirmed. These patients will receive standard treatment with empagliflozin. Additionally, these patients will be administered 200 milliliters of milk. Reduction in microalbuminuria. Timepoint: At time point zero (prior to drug administration), three months, and six months after drug administration. Method of measurement: laboratory test. Enhancement in GFR (Glomerular Filtration Rate). Timepoint: At time point zero (prior to drug administration), one month, three months, and six months after drug administration. Method of measurement: Laboratory test and Calculation of the Glomerular Filtration Rate (GFR). Improvement in creatinine levels. Timepoint: At time point zero (prior to drug administration), one month, three months, and six months after drug administration. Method of measurement: Laboratory test. Reduction in blood glucose. Timepoint: At time point zero (prior to drug administration), one month, three months, and six months after drug administration. Method of measurement: Laboratory test. Reduction in blood pressure. Timepoint: At time point zero (prior to drug administration), one month, three months, and six months after drug administration. Method of measurement: Barometer. Reduction in HbA1C. Timepoint: At time point zero (prior to drug administration), three months, and six months after drug administration. Method of measurement: laboratory test. Reduction in the incidence of urinary tract infections. Timepoint: At time point zero (prior to drug administration), one month, three months, and six months after drug administration. Method of measurement: laboratory test. Decrease in serum levels of NO (its metabolites). Timepoint: At time point zero (prior to drug administration), three months, and six months after drug administration. Method of measurement: ELISA. Reduction in the levels of inflammatory factors((TNF)-α, (IL)-6, (IL)-1β. Timepoint: At time point zero (prior to drug administration), three months, and six months after drug administration. Method of measurement: ELISA. Mashhad University of Medical Sciences Approved 2023-10-27 Research Ethics committees of Mashhad University of Medical Sciences Daneshgah street, the central organization of University, Quraishi construction mashhad Razavi Khorasan Iran (Islamic Republic of)