Diabetes, Peritoneal Dialysis
Conditions
Brief summary
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
After breakfast daily, use a bag of amino acid (15) peritoneal dialysis solution (2L), followed by treatment with glucose peritoneal dialysis solution (lactate).
Sponsors
Chengdu Qingshan Likang Pharmaceutical Co., Ltd
The People's Hospital of Gaozhou
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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: 1. Individuals allergic to any component of amino acid (15) peritoneal dialysis fluid; 2. Serum urea level\>38 mmol/l; 3. Metabolic acidosis (CO2 binding capacity\<22mmol/L); 4. Severe hypokalemia (blood potassium\<2.5mmol/L); 5. Various congenital amino acid metabolism abnormalities; 6. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | Day 0、Day 90 |
Secondary
| Measure | Time frame |
|---|---|
| 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. | 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. | 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. | Day 0、Day 90 |
| 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. | 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. | 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. | 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. | 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. | Day 0、Day 30、Day 90 |
Countries
China
Contacts
Primary ContactShanshan Deng
Outcome results
None listed