Peritoneal DialysisNCT07077538
Clinical Study of the Use of Amino Acid Peritoneal Dialysate in Diabetic Patients
A study testing Amino acid peritoneal dialysis solution in people with Peritoneal Dialysis and Diabetes, run by The People's Hospital of Gaozhou at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peritoneal Dialysis, Diabetes
- What is being tested?
- Amino acid peritoneal dialysis solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Medical Ethics Committee of Gaozhou People's Hospital
Gaozhou, Guangdong, 525200
Yuyin Chen, 8619103069079, GYLL0668@163.com
About this study
Official title: A Single Center, Open, Prospective, Self-control Clinical Study on the Use of Amino Acid Peritoneal Dialysis Fluid in Diabetes 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.
- Conditions
- Peritoneal Dialysis, Diabetes
- Being tested
- Amino acid peritoneal dialysis solution
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amino acid peritoneal dialysis solutionDrug
After breakfast daily, use a bag of amino acid (15) peritoneal dialysis solution (2L), followed by treatment with glucose peritoneal dialysis solution (lactate).
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Not described Receives: Drug: Amino acid peritoneal dialysis solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 0、Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start30 Jul 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Peritoneal DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The People's Hospital of Gaozhou
- Sponsor type
- University, hospital or other
- Collaborators
- Chengdu Qingshan Likang Pharmaceutical Co., Ltd
- Responsible party
- Principal investigator, deng shanshan, The People's Hospital of Gaozhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07077538
- Sponsor's protocol ID
- GYLLPJ-2025046
- Status last verified
- Jul 2025
- First submitted
- 24 Jun 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21511838Qayyum 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.
PubMed 26960210Gomez 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.
PubMed 28927285
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open, Prospective, Self-control Clinical Study on the Use of Amino Acid Peritoneal Dialysis Fluid in Diabetes Patients
- ClinicalTrials.gov ID
- NCT07077538
- Acronym / sponsor ID
- GYLLPJ-2025046
- Conditions
- Peritoneal Dialysis, Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- The People's Hospital of GaozhouUniversity, hospital or other
- Collaborators
- Chengdu Qingshan Likang Pharmaceutical Co., Ltd
- Study start
- 30 Jul 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: Amino acid peritoneal dialysis solution |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amino acid peritoneal dialysis solutionAfter breakfast daily, use a bag of amino acid (15) peritoneal dialysis solution (2L), followed by treatment with glucose peritoneal dialysis solution (lactate). | Drug | experimental group |
Primary outcome
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
8 secondary outcomes
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
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
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Background: PubMed 21511838Duong 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.
- Background: PubMed 26960210Qayyum 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.
- Background: PubMed 28927285Gomez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amino acid peritoneal dialysis solution in people with Peritoneal Dialysis and Diabetes, run by The People's Hospital of Gaozhou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shanshan Deng (8613927596600, 276531255@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07077538, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.