Clinical Study of the Use of Amino Acid Peritoneal Dialysate in Diabetic Patients

NCT07077538 | Recruiting

• 1 other identifier: GYLLPJ-2025046
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Peritoneal Dialysis; Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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.

  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

Study Arms (1)

experimental group

EXPERIMENTAL

Drug: Amino acid peritoneal dialysis solution

Interventions

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).

experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• %\<glycated hemoglobin (HbA1c) level ≤ 8.5%;
• g/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.

You may not qualify if:

• 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 dialysis fluid;
• 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 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.

Sponsors & Collaborators

• The People's Hospital of Gaozhou: lead
• Chengdu Qingshan Likang Pharmaceutical Co., Ltd: collaborator

Study Sites (1)

Medical Ethics Committee of Gaozhou People's Hospital

Gaozhou, Guangdong, 525200, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 21511838 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.

  PMID: 26960210 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.

  PMID: 28927285 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Shanshan Deng

CONTACT

8613927596600; 276531255@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 22, 2025
• Study Start: July 30, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)