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A single-center, open, prospective, self-controlled clinical study on the use of amino acid peritoneal dialysate in patients with diabetes

A single-center, open, prospective, self-controlled clinical study on the use of amino acid peritoneal dialysate in patients with diabetes

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500114313
Enrollment
Unknown
Registered
2025-12-10
Start date
2025-06-17
Completion date
Unknown
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease Stage 5/diabetic nephropathy/Peritoneal dialysis replacement therapy

Interventions

Diabetic patients with amino acid peritoneal dialysate grouping:None

Sponsors

Gaozhou People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1: People with type I or type II diabetes ages 18 to 75 (including 18 and 75 years old) have no gender restrictions; 2: Stable peritoneal dialysis patients, peritoneal dialysis treatment for >=3 months; 3: Use 3-5 bags of peritoneal dialysate every day; 4: 6.0%<Glycoated hemoglobin (HbA1c) level <=8.5%; 5: 90g/L<=hemoglobin concentration <=130g/L; 6: Steady use of erythropoietin and rosalasta within one month; 7: The fluctuation of the carbohydrate energy supply ratio is less than 15% in the three months before enrollment; 8: No amino acid (15) peritoneal dialysate was used in the first 3 months of enrollment; 9: The prescription of hypoglycemic drugs for the patient has not been adjusted in the past month; 10: In the past month, the patient's diet structure and food intake have remained stable.

Exclusion criteria

Exclusion criteria: 1: Peritonitis occurred in the last 3 months; 2: Using Ecodextrin Peritoneal Dialysate Fluid; 3: There are contraindications for amino acid (15) peritoneal dialysis solution: Patients with allergies to any component of amino acid (15) peritoneal dialysis solution; Patients with a serum urea level > 38 mmol/L; Patients with metabolic acidosis (CO2 combining power < 22 mmol/L); Patients with severe hypokalemia (serum potassium < 2.5 mmol/L); Patients with various congenital amino acid metabolic disorders; Patients with liver dysfunction (alanine aminotransferase level exceeding 2.5 times the upper limit of the normal range); 4: Complicated with hemoglobinopathy, such as thalassemia, sickle cell disease, etc; 5: It is expected that the patient may undergo kidney transplantation during the trial period; 6: Participated in other clinical studies.

Design outcomes

Primary

MeasureTime frame
Glycated hemoglobin;

Secondary

MeasureTime frame
Blood routine;Blood biochemistry;C-reactive protein;

Countries

China

Contacts

Public ContactDeng Shanshan

Gaozhou People's Hospital

276531255@qq.com+86 668 662 2919

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026