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

Launched by THE PEOPLE'S HOSPITAL OF GAOZHOU · Jul 20, 2025

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ClinConnect Summary

This clinical study is looking at how a special type of dialysis fluid containing amino acids affects blood sugar control in people with diabetes who are already receiving peritoneal dialysis. Peritoneal dialysis is a treatment that helps remove waste and extra fluid from the body when the kidneys aren’t working well. The researchers want to see if using this amino acid solution for 90 days can improve a measure of blood sugar called glycosylated hemoglobin (or HbA1c), which shows how well blood sugar has been controlled over time.

To join the study, participants need to be adults between 18 and 75 years old with type 1 or type 2 diabetes who have been on peritoneal dialysis for at least three months. They should have fairly stable blood sugar levels, take a certain amount of dialysis fluid daily, and have steady medication and diet routines. During the study, participants will switch to the amino acid dialysis solution, and doctors will monitor changes in their blood sugar and overall health. People with recent infections, allergies to the dialysis fluid, serious liver or blood problems, or those expecting a kidney transplant soon would not be eligible. This study is currently recruiting patients who meet these criteria.

Gender

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Eligibility criteria

• 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.