NCT07077538 Clinical Study of the Use of Amino Acid Peritoneal Dialysate in Diabetic Patients
| NCT ID | NCT07077538 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The People's Hospital of Gaozhou |
| Condition | Peritoneal Dialysis |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-07-30 |
| Primary Completion | 2026-06-30 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
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