NCT07077538招募中不适用
A Single Center, Open, Prospective, Self-control Clinical Study on the Use of Amino Acid Peritoneal Dialysis Fluid in Diabetes Patients
The People's Hospital of Gaozhou1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年7月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
experimental group
Experimental
干预措施: Amino acid peritoneal dialysis solution (Drug)
结局指标
主要结局
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.
时间窗: Day 0、Day 90
次要结局
- 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 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 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 hypoglycemic drugs 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 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 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 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 prealbumin relative to baseline after 90 days of using amino acid (15) peritoneal dialysate in diabetes patients undergoing peritoneal dialysis.(Day 0、Day 90)
研究者
deng shanshan
Director
The People's Hospital of Gaozhou
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Drug-drug Interaction Study of SHR6390 on Healthy Chinese VolunteersAdvanced Solid TumorNCT04973020Jiangsu HengRui Medicine Co., Ltd.20
已完成
2 期
Short-course Radiotherapy Followed by Tislelizumab + CapeOX in the Treatment for Locally Advanced Rectal CancerLocally Advanced Rectal CancerNCT05086627Hebei Medical University Fourth Hospital118
已完成
1 期
Study on Drug Interaction of Metformin Tablets and HRS-7535 Tablets in Healthy HumanDiabetesNCT06727838Shandong Suncadia Medicine Co., Ltd.18
已完成
不适用
Evaluation of Siddha herbal formulation, Vipro, in the management of uncomplicated respiratory infectionsCTRI/2020/06/025559Buy Happy Marketing LLP60
已完成
不适用
Valvosoft First-In-Human Study in Severe Symptomatic Aortic StenosisAortic Valve StenosisNCT04665596Cardiawave SA10