Investigation of the effect of a combination of specific amino acids oral supplements in patients with diabetic nephropathy: a randomized controlled phase 1 clinical trial

In order to reduce the progression of nephropathy in diabetic patients, a clinical trial study has been designed to evaluate the effectiveness of oral supplementation resulting from the combination of 7 amino acids in diabetic nephropathy patients with a limited protein diet. In phase 1, the safety of the compound is evaluated.

A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 1 on 60 patients. block Randomization method is used for randomization.

60 eligible diabetic nephropathy patients are selected in the office of a nephrologist. Patients are prescribed a low-protein diet of 0.6 to 0.8 grams per kilogram per day. 30 patients will be considered as controls and will receive a placebo, and 30 patients will be treated with oral supplements. The double-blind method is used that both patients, physicians and evaluators of results are not aware of the supplementation group or placebo.

Inclusion criteria: Men or women over 18 years of age with type 1 or type II diabetes and kidney disease with a 30-300 mg urinary albumin level in 24 hours. Exclusion criteria: People with chronic inflammatory or autoimmune diseases, CKD due to reasons other than diabetes, organ transplants, blood pressure 16 to 9 and above, etc., and if patients do not follow a diet with limited protein.

The oral supplement contains 1 g of glycine, 1 g of L -glutamic acid, 1 g of L -glutamine, 0.7 g of alanine, 0.5 g of lysine, 0.5 g of arginine plus 1 g of creatine. The contents are diluted in 50 ml of water and patients will consume it twice a day for 3 months. The starch powder will be used as a placebo.

Measurement of biochemical parameters to assess the safety of compound: creatinine, blood urea nitrogen, sodium and potassium and 24-hour urinary albumin

In this study, we will use the restricted randomization method of block randomization. Blocking is usually used to balance the number of samples assigned to each of the study groups. This feature helps researchers to equate the number of samples assigned to each of the study groups in cases where intermediate analyzes are required during the sampling process. In this two-group experiment, we will have blocks with 60 members (including 30 participants in the intervention group and 30 participants in the control group). Randomization tool is also Random allocation software that is able to generate random sequences by blocking method. We also use random allocation concealment with the central method so that the assigned group is not known before the individual is assigned. In this method, a random sequence is provided to a specific person or center, and the researcher, based on the order in which participants enter the study, communicates with the relevant center about the group.

In this study, to reduce bias related to the intervention and evaluate the consequences, the double-blind method is followed. In this method, the trial is planned in such a way that the participant does not know which of the two control or test groups it belongs to, and the physician and the results evaluator (data analyzer) do not know what treatment is for which patient. Therefore, only the lead researcher is aware of the grouping of participants. One of the most common methods of blinding in RCTs is the use of seemingly identical drugs. In this study, we will use amino acid powder as a “active” drug and starch powder as a "placebo" and we will provide both in the same cans to the doctor and finally to the patients. It is impossible for patients and physicians to determine which drug and which placebo. To blind the results evaluator, we use the coding method in such a way that for each patient, regardless of the existing grouping, a code is assigned that is stored in the main file of information with the main researcher and patient information and data will be given to the evaluator with this code.