Phase
Condition
Diabetic Macular Edema
Diabetic Vitreous Hemorrhage
Diabetic Foot Ulcers
Treatment
Amino acid peritoneal dialysis solution
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 treatmentfor ≥ 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 beforeenrollment is less than 15%;
Not using amino acid (15) peritoneal dialysis solution for the first 3 months beforeenrollment;
Within the past month, the patient's prescription for hypoglycemic drugs has notbeen adjusted;
Within the past month, the patient's dietary structure and food intake have remainedstable.
Exclusion
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 dialysisfluid;
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 theupper 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.
Study Design
Connect with a study center
Medical Ethics Committee of Gaozhou People's Hospital
Gaozhou, Guangdong 525200
ChinaActive - Recruiting

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