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

The People's Hospital of Gaozhou

Status: Enrolling

Conditions: Diabetes; Peritoneal Dialysis

Treatments: Drug: Amino acid peritoneal dialysis solution

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07077538

GYLLPJ-2025046

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 treatment for ≥ 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 before enrollment is less than 15%;
• Not using amino acid (15) peritoneal dialysis solution for the first 3 months before enrollment;
• Within the past month, the patient's prescription for hypoglycemic drugs has not been adjusted;
• Within the past month, the patient's dietary structure and food intake have remained stable.

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 dialysis fluid;
  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 the upper 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

experimental group

Experimental group

Treatment:

Drug: Amino acid peritoneal dialysis solution