Actively Recruiting
Clinical Study of the Use of Amino Acid Peritoneal Dialysate in Diabetic Patients
Led by The People's Hospital of Gaozhou · Updated on 2025-07-22
70
Participants Needed
1
Research Sites
47 weeks
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
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.
CONDITIONS
Official Title
Clinical Study of the Use of Amino Acid Peritoneal Dialysate in Diabetic Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 63 months
- Use 3-5 bags of peritoneal dialysis solution daily
- Glycated hemoglobin (HbA1c) level greater than 6.0% and less than or equal to 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 three months before enrollment
- Not using amino acid (15) peritoneal dialysis solution in the three months before enrollment
- Hypoglycemic drug prescriptions not adjusted within the past month
- Dietary structure and food intake stable within the past month
You will not qualify if you...
- Peritonitis occurred within the past 3 months
- Use of Acodextrin peritoneal dialysis solution
- Allergy to any component of amino acid (15) peritoneal dialysis fluid
- Serum urea level greater than 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 (alanine aminotransferase levels more than 2.5 times the upper limit of normal)
- 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
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Trial Site Locations
Total: 1 location
1
Medical Ethics Committee of Gaozhou People's Hospital
Gaozhou, Guangdong, China, 525200
Actively Recruiting
Research Team
S
Shanshan Deng
CONTACT
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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