Amino acid peritoneal dialysis for adults with diabetes

A Single Center, Open, Prospective, Self-control Clinical Study on the Use of Amino Acid Peritoneal Dialysis Fluid in Diabetes Patients

This study will try an amino acid–based peritoneal dialysis solution in adults with diabetes on peritoneal dialysis to see if their hemoglobin A1c changes after 90 days.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The People's Hospital of Gaozhou (Academic / other)
• Locations: 1 site (Gaozhou, Guangdong)
• Trial ID: NCT07077538 on ClinicalTrials.gov

What this trial studies

This single-center, open-label, prospective, self-controlled study enrolls adults with type 1 or type 2 diabetes who have been on peritoneal dialysis for at least three months. Participants will use an amino acid–containing peritoneal dialysis solution while continuing their usual regimen of 3–5 bags per day. Hemoglobin A1c will be measured at baseline and again 90 days after starting the amino acid solution, with hemoglobin levels and stability of erythropoietin/statin therapy monitored. Each participant serves as their own control to observe within-person changes in glycemic markers.

Who should consider this trial

Good fit: Adults 18–75 years with type 1 or type 2 diabetes who have been on stable peritoneal dialysis for at least three months, use 3–5 bags daily, have HbA1c roughly between 6% and 8.5%, and have stable medications and diet are ideal candidates.

Not a fit: Patients with recent peritonitis, those using acodextrin solutions, with contraindications to amino acids, unstable hemoglobin, or recent changes in hypoglycemic therapy or diet are unlikely to receive benefit.

Why it matters

Potential benefit: If successful, the approach could help improve blood sugar control and support nutritional status in diabetic patients on peritoneal dialysis.

How similar studies have performed: Amino acid–containing dialysis solutions have shown nutritional benefits in small prior studies, but evidence that they lower HbA1c in diabetic peritoneal dialysis patients is limited.

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.

Where this trial is running

Gaozhou, Guangdong

• Medical Ethics Committee of Gaozhou People's Hospital — Gaozhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Shanshan Deng

Conditions Peritoneal Dialysis; Diabetes