Glycemic control and survival in peritoneal dialysis patients with diabetes mellitus.
Uyen Duong, Rajnish Mehrotra, Miklos Z Molnar...
https://pubmed.ncbi.nlm.nih.gov/21511838Actively Recruiting
Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID07077538
A Single Center, Open, Prospective, Self-control Clinical Study on the Use of Amino Acid Peritoneal Dialysis Fluid in Diabetes Patients
Led by The People's Hospital of Gaozhou · Updated on 2025-07-22
70
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
The People's Hospital of Gaozhou
Lead Sponsor
C
Chengdu Qingshan Likang Pharmaceutical Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of using an amino acid (15) peritoneal dialysis solution in patients with diabetes who are undergoing peritoneal dialysis. This single-center, open, prospective, self-controlled clinical study aims to observe changes in glycosylated hemoglobin (HbA1c) 90 days after starting the amino acid dialysis solution. The study focuses on diabetic patients already receiving peritoneal dialysis to better understand how this treatment may influence blood sugar control and related health measures. Participants will use one bag (2 liters) of amino acid (15) peritoneal dialysis solution daily after breakfast, followed by treatment with glucose peritoneal dialysis solution (lactate). The study period involves monitoring patients from the start (Day 0) through 90 days of treatment with this amino acid solution. This intervention is assessed without a comparison group, as each patient serves as their own control. During the study, participants will have regular assessments of blood markers including glycosylated hemoglobin, fasting blood glucose, serum albumin, hemoglobin, prealbumin, daily urine volume, ultrafiltration volume, Kt/v, creatinine clearance rate (Ccr), and hypoglycemic drug use. These measurements will be taken at baseline, 30 days, and 90 days to track changes over time. The total study duration for each participant is 90 days, with ongoing monitoring for safety and effectiveness of the amino acid dialysis solution.
CONDITIONS
Brief Title
Clinical Study of the Use of Amino Acid Peritoneal Dialysate in Diabetic Patients
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Type I or II diabetes patients aged 18 to 75 years, any gender
- Stable peritoneal dialysis treatment for 3 months or longer
- Use 3 to 5 bags of peritoneal dialysis solution daily
- Glycated hemoglobin (HbA1c) level between 6.0% and 8.5%
- Hemoglobin concentration between 90g/L and 130g/L
- Stable use of erythropoietin and rosuvastatin
- Carbohydrate energy supply ratio fluctuation less than 15% in the 3 months before enrollment
- No use of amino acid (15) peritoneal dialysis solution in the 3 months before enrollment
- No adjustment in hypoglycemic drug prescription in the past month
- Stable dietary structure and food intake in the past month
You will not qualify if you...
- Peritonitis within the past 3 months
- Use of Acodextrin peritoneal dialysis solution
- Allergic to any component of amino acid (15) peritoneal dialysis fluid
- Serum urea level over 38 mmol/l
- Metabolic acidosis (CO2 binding capacity less than 22 mmol/L)
- Severe hypokalemia (blood potassium less than 2.5 mmol/L)
- Congenital amino acid metabolism abnormalities
- Liver dysfunction with alanine aminotransferase levels over 2.5 times the normal upper limit
- Combined hemoglobinopathies such as thalassemia or sickle cell disease
- Expected kidney transplantation during the trial period
- Participation in other clinical studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 90 days
Participants use a bag of amino acid peritoneal dialysis solution (2L) after breakfast daily, followed by treatment with glucose peritoneal dialysis solution.
Visits on Day 0, Day 30, and Day 90
Trial Site Locations
Total: 1 location
1
Medical Ethics Committee of Gaozhou People's Hospital
Gaozhou, Guangdong, China, 525200
Actively Recruiting
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Research Team
S
Shanshan Deng
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
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.
Ahad Qayyum, Tahseen A Chowdhury, Elizabeth Ley Oei...
https://pubmed.ncbi.nlm.nih.gov/26960210Impact of a Basal-Bolus Insulin Regimen on Metabolic Control and Risk of Hypoglycemia in Patients With Diabetes Undergoing Peritoneal Dialysis.
Ana María Gómez, Santiago Vallejo, Freddy Ardila...
https://pubmed.ncbi.nlm.nih.gov/28927285