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| Name | Class |
|---|---|
| Chengdu Qingshan Likang Pharmaceutical Co., Ltd | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amino acid peritoneal dialysis solution | Drug | After breakfast daily, use a bag of amino acid (15) peritoneal dialysis solution (2L), followed by treatment with glucose peritoneal dialysis solution (lactate). |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 serum albumin relative to the baseline after 90 days of using amino acid (15) peritoneal dialysate in diabetes patients undergoing peritoneal dialysis. |
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Inclusion Criteria:
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:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shanshan Deng | Contact | 8613927596600 | 276531255@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Ethics Committee of Gaozhou People's Hospital | Recruiting | Gaozhou | Guangdong | 525200 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21511838 | Background | 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. | |
| 26960210 | Background | 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. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| 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 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 |
| 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 |
| 28927285 | Background | 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. |