Health TrialsbyHealthPanel

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

ConditionsPeritoneal DialysisDiabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe People's Hospital of Gaozhou

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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%;

Disqualifiers

Peritonitis has occurred within the past 3 months;

Use Acodextrin peritoneal dialysis solution;

Individuals allergic to any component of amino acid (15) peritoneal dialysis fluid;

Serum urea level>38 mmol/l;

Trial design

Design model

Single group

Treatments tested in this trial

  • 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).

Treatment groups

70 Participants
are divided into 1 treatment group
Group A: experimental groupExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The People's Hospital of Gaozhou

Lead sponsor

Chengdu Qingshan Likang Pharmaceutical Co., Ltd

Collaborator

Source ClinicalTrials.gov
Apply now