Recruiting NCT07077538
Clinical Study of the Use of Amino Acid Peritoneal Dialysate in Diabetic Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Amino acid peritoneal dialysis solution.
- Who it may be relevant to
- Registry conditions: Peritoneal Dialysis, Diabetes. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Single Center, Open, Prospective, Self-control Clinical Study on the Use of Amino Acid Peritoneal Dialysis Fluid in Diabetes Patients
Overview
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.
Interventions
- Drug 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).
Primary outcome measures
- 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. [Time frame: Day 0、Day 90]
Secondary outcome measures (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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: Day 0、Day 90]
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:
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Medical Ethics Committee of Gaozhou People's Hospital — Gaozhou
Publications
- 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
Identifiers
NCT: NCT07077538 · GYLLPJ-2025046