]>
IRCT20210822052252N1 IRCT 2021-09-05 Esfahan University of Medical Sciences investigation of the effect of specific amino acids in diabetic nephropathy DN or DKD 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 2021-09-23 anticipated 60 Complete https://irct.ir/trial/58236 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 1 diabetic nephropathy. Intervention 1: Intervention group: 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 (PH = 6.4) and patients will consume it twice a day for 3 months. Intervention 2: Control group: Starch powder will be used as a placebo for patients in the control group. 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 more information.
public Alieh Gholaminejad
Regenerative Medicine Lab, Isfahan University of Medical Sciences, Hezar Jerib Avenue, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 9076 a.gholaminejad@res.mui.ac.ir Esfahan University of Medical Sciences scientific Alieh Gholaminejad
Regenerative Medicine Lab, Isfahan University of Medical Sciences, Hezar Jerib Avenue, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 9076 a.gholaminejad@res.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Age 18 years or older men or non-pregnant and non-lactating women with type 1 or type II diabetes and kidney disease Participants with albumin in urine: Diabetic patients whose albumin level is 30-300 mg / 24h is used for this study (stage 3 of the stages of diabetic nephropathy) Willingness and ability to consciously consent and cooperate with the protocol, including discontinuation of current hypertension medications if necessary 18 years no limit Both Pregnant or lactating women People with inflammatory or chronic autoimmune diseases People with chronic kidney disease for reasons other than diabetes People with organ transplants People with blood pressure 16 over 9 and above People with hepatitis B or C viral liver infection, liver cirrhosis or significant liver disease People with recent gastrointestinal bleeding People with acute kidney damage in the 3 months before screening Individuals who have undergone major surgery within 3 months prior to screening or plan to have it during the study period. People with HIV infection with the virus that causes AIDS. People with heart disease that is not considered stable. People with active cancer or another disease that greatly increases the risk of cancer. People with the need to take drugs that alter the immune system. The patient's do not follow a diet with limited protein. E11.21 Type 2 diabetes mellitus with diabetic nephropathy Treatment - Drugs Placebo Intervention group: 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 (PH = 6.4) and patients will consume it twice a day for 3 months. Control group: Starch powder will be used as a placebo for patients in the control group. Creatinine (GFR). Timepoint: at the beginning of the trial, and after each month. Method of measurement: Enzymatic calorimetric assay. Blood urea nitrogen. Timepoint: at the beginning of the trial, and after each month. Method of measurement: Enzymatic method (urease). Sodium and potassium in serum. Timepoint: at the beginning of the trial, and after each month. Method of measurement: Electrolyte analyzer. 24-hour urinary albumin. Timepoint: at the beginning and end of the trial. Method of measurement: Bromocresol green. Colorimetric. Esfahan University of Medical Sciences Approved 2021-05-08 ethics committee of Isfahan university of medical sciences Hezar Jerib street, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)