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investigation of the effect of specific amino acids in diabetic nephropathy

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

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210822052252N1
Enrollment
60
Registered
2021-09-05
Start date
2021-09-23
Completion date
Unknown
Last updated
2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetic nephropathy. Type 2 diabetes mellitus with diabetic nephropathy

Interventions

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

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAlieh Gholaminejad

Esfahan University of Medical Sciences

a.gholaminejad@res.mui.ac.ir+98 31 3792 9076

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026