investigation of the effect of specific amino acids in diabetic nephropathy

Phase 1

Recruiting

• Conditions: diabetic nephropathy.; Type 2 diabetes mellitus with diabetic nephropathy; E11.21

• Registration Number: IRCT20210822052252N1
• Lead Sponsor: Esfahan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 November 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.