Amino acid peritoneal dialysis for adults with diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Shanshan Deng
• Email: 276531255@qq.com
• Phone: 8613927596600

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.