Investigating the additional effect of methylene blue to empagliflozin on nephropathy in patients with type II diabetes

Determination of the additional effect of Methylene Blue to Empagliflozin on nephropathy in patients with Type 2 Diabetes and its comparison with the control Group"

A clinical trial with the control group, parallel, blinding in assessors, analysts, and sample allocators, randomized, phase 2 on 50 patients. Blocking will be used for randomization

Patients with early-stage nephropathy and microalbuminuria, confirmed by two urine tests with a ratio of 30-300 mg/g, are treated by an endocrinologist at Qaem Hospital. The attending physician's criteria determine admission and discharge, with willing patients randomly assigned to the control or intervention group using block randomization.

age:25 to 65, and having a GFR between 25 and 90. They must not have liver insufficiency, active liver disease, active infection, sepsis, or polycystic kidney disease. Inclusion criteria also involve non-professional athletes, individuals not receiving insulin treatment, no acute kidney failure unrelated to diabetes, no history of heart or vascular diseases, G6PD deficiency, well-controlled blood pressure, and no prior cancer or endocrine diseases

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.

Primary Outcome : Reduction in microalbuminuria. Improvement in GFR rate. Secondary Outcome: Improvement in creatinine levels. Reduction in blood glucose, HbA1C, and blood pressure. Decreased incidence of urinary tract infections. Decreased serum levels of NO metabolites. Reduction in levels of inflammatory markers."

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).