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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Amino acid peritoneal dialysis solution
  After breakfast daily, use a bag of amino acid (15) peritoneal dialysis solution (2L), followed by treatment with glucose peritoneal dialysis solution (lactate).

Первичные конечные точки

• To observe the changes of glycosylated hemoglobin (HbA1c) in peritoneal dialysis patients with diabetes after 90 days of using amino acid (15) peritoneal dialysis solution. [Срок оценки: Day 0、Day 90]

Вторичные конечные точки (8)

• To observe the changes of fasting blood glucose relative to the baseline after 30 and 90 days of using amino acid (15) peritoneal dialysate in diabetes patients undergoing peritoneal dialysis. [Срок оценки: Day 0、Day 30、Day 90]
• To observe the changes of serum albumin relative to the baseline after 90 days of using amino acid (15) peritoneal dialysate in diabetes patients undergoing peritoneal dialysis. [Срок оценки: Day 0、Day 90]
• To observe the changes of hemoglobin relative to the baseline after 90 days of using amino acid (15) peritoneal dialysate in diabetes patients undergoing peritoneal dialysis. [Срок оценки: Day 0、Day 90]
• To observe the changes of prealbumin relative to baseline after 90 days of using amino acid (15) peritoneal dialysate in diabetes patients undergoing peritoneal dialysis. [Срок оценки: Day 0、Day 90]
• To observe the relative baseline changes of daily urine volume and ultrafiltration volume after 30 and 90 days of using amino acid (15) peritoneal dialysate in diabetes patients undergoing peritoneal dialysis. [Срок оценки: Day 0、Day 30、Day 90]
• To observe the changes of Kt/v in peritoneal dialysis patients with diabetes 90 days after using amino acid (15) peritoneal dialysis solution. [Срок оценки: Day 0、Day 90]
• To observe the changes of Ccr in peritoneal dialysis patients with diabetes 90 days after using amino acid (15) peritoneal dialysis solution. [Срок оценки: Day 0、Day 90]
• To observe the changes of hypoglycemic drugs in peritoneal dialysis patients with diabetes 90 days after using amino acid (15) peritoneal dialysis solution. [Срок оценки: Day 0、Day 90]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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:

• Individuals allergic to any component of amino acid (15) peritoneal dialysis fluid;
• Serum urea level>38 mmol/l;
• Metabolic acidosis (CO2 binding capacity<22mmol/L);
• Severe hypokalemia (blood potassium<2.5mmol/L);
• Various congenital amino acid metabolism abnormalities;
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Medical Ethics Committee of Gaozhou People's Hospital — Gaozhou

Публикации

• Duong U, Mehrotra R, Molnar MZ, Noori N, Kovesdy CP, Nissenson AR, Kalantar-Zadeh K. Glycemic control and survival in peritoneal dialysis patients with diabetes mellitus. Clin J Am Soc Nephrol. 2011 May;6(5):1041-8. doi: 10.2215/CJN.08921010. Epub 2011 Apr 21. PMID 21511838
• Qayyum A, Chowdhury TA, Oei EL, Fan SL. Use of Continuous Glucose Monitoring in Patients with Diabetes Mellitus on Peritoneal Dialysis: Correlation with Glycated Hemoglobin and Detection of High Incidence of Unaware Hypoglycemia. Blood Purif. 2016;41(1-3):18-24. doi: 10.1159/000439242. Epub 2015 Oct 20. PMID 26960210
• Gomez AM, Vallejo S, Ardila F, Munoz OM, Ruiz AJ, Sanabria M, Bunch A, Morros E, Kattah L, Garcia-Jaramillo M, Leon-Vargas F. Impact of a Basal-Bolus Insulin Regimen on Metabolic Control and Risk of Hypoglycemia in Patients With Diabetes Undergoing Peritoneal Dialysis. J Diabetes Sci Technol. 2018 Jan;12(1):129-135. doi: 10.1177/1932296817730376. Epub 2017 Sep 20. PMID 28927285

Идентификаторы

NCT: NCT07077538 · GYLLPJ-2025046

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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