Clinical Study of the Use of Amino Acid Peritoneal Dialysate in Diabetic Patients

Last updated: July 20, 2025
Sponsor: The People's Hospital of Gaozhou
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetic Macular Edema

Diabetic Vitreous Hemorrhage

Diabetic Foot Ulcers

Treatment

Amino acid peritoneal dialysis solution

Clinical Study ID

NCT07077538
GYLLPJ-2025046
  • Ages 18-75
  • All Genders

Study Summary

The study is a single center, open, prospective, self controlled clinical study. The patients with diabetes who are to be enrolled in peritoneal dialysis are to observe the changes of glycosylated hemoglobin relative to the baseline 90 days after using amino acid (15) peritoneal dialysis solution.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Type I or II diabetes patients aged 18 to 75 years (including 18 and 75 years),regardless of gender;

  • Stable peritoneal dialysis patients who have undergone peritoneal dialysis treatmentfor ≥ 3 months;

  • Use 3-5 bags of peritoneal dialysis solution daily;

  • 6.0%<glycated hemoglobin (HbA1c) level ≤ 8.5%;

  • 90g/L ≤ Hemoglobin concentration ≤ 130g/L

  • Stable use of erythropoietin and rosuvastatin;

  • The fluctuation of carbohydrate energy supply ratio in the first 3 months beforeenrollment is less than 15%;

  • Not using amino acid (15) peritoneal dialysis solution for the first 3 months beforeenrollment;

  • Within the past month, the patient's prescription for hypoglycemic drugs has notbeen adjusted;

  • Within the past month, the patient's dietary structure and food intake have remainedstable.

Exclusion

Exclusion Criteria:

  • Peritonitis has occurred within the past 3 months;

  • Use Acodextrin peritoneal dialysis solution;

  • Contraindications for the presence of amino acids (15) in peritoneal dialysis fluid:

  1. Individuals allergic to any component of amino acid (15) peritoneal dialysisfluid;

  2. Serum urea level>38 mmol/l;

  3. Metabolic acidosis (CO2 binding capacity<22mmol/L);

  4. Severe hypokalemia (blood potassium<2.5mmol/L);

  5. Various congenital amino acid metabolism abnormalities;

  6. Liver dysfunction (alanine aminotransferase levels exceeding 2.5 times theupper limit of normal);

  • Combined hemoglobinopathies: such as thalassemia, sickle cell disease, etc;

  • It is expected that kidney transplantation may be accepted during the trial period;

  • Participated in other clinical studies.

Study Design

Total Participants: 70
Treatment Group(s): 1
Primary Treatment: Amino acid peritoneal dialysis solution
Phase:
Study Start date:
July 30, 2025
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Medical Ethics Committee of Gaozhou People's Hospital

    Gaozhou, Guangdong 525200
    China

    Active - Recruiting

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