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NCT Number: NCT07077538

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

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Ethics Committee of Gaozhou People's Hospital

Gaozhou, Guangdong, 525200, China

Location status: Recruiting

Location contact

Yuyin Chen

CONTACT

[email protected]

8619103069079

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.

Treatment and study plan

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).

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.

    Time frame: Day 0、Day 90

Secondary outcomes

  1. 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.

    Time frame: Day 0、Day 30、Day 90

  2. 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.

    Time frame: Day 0、Day 90

  3. 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.

    Time frame: Day 0、Day 90

  4. 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.

    Time frame: Day 0、Day 90

  5. 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.

    Time frame: Day 0、Day 30、Day 90

  6. To observe the changes of Kt/v in peritoneal dialysis patients with diabetes 90 days after using amino acid (15) peritoneal dialysis solution.

    Time frame: Day 0、Day 90

  7. To observe the changes of Ccr in peritoneal dialysis patients with diabetes 90 days after using amino acid (15) peritoneal dialysis solution.

    Time frame: Day 0、Day 90

  8. To observe the changes of hypoglycemic drugs in peritoneal dialysis patients with diabetes 90 days after using amino acid (15) peritoneal dialysis solution.

    Time frame: Day 0、Day 90

Study contacts

Contact information is provided by the study sponsor or research team.

Shanshan Deng

CONTACT

[email protected]

8613927596600

Sponsors and collaborators

Lead sponsor

The People's Hospital of Gaozhou

Other

Collaborators

  • Chengdu Qingshan Likang Pharmaceutical Co., Ltd

Registry information

Official study title

A Single Center, Open, Prospective, Self-control Clinical Study on the Use of Amino Acid Peritoneal Dialysis Fluid in Diabetes Patients

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 22, 2025
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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