跳至主要内容
临床试验/NCT05922852
NCT05922852招募中不适用

the Effect of Novel Antidiabetic Drug Combined With Angiotensin Receptor/Neprilysin Inhibitor Over Monotherapy on Urinary Protein in Patients With Type 2 Diabetes

Peking University Third Hospital2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
2
主要终点
urinary protein changes

研究概览

简要总结

The purpose of this study is to determine whether the combination of SGLT2i and ARNI in type 2 diabetic patients with combined albuminuria could reduce urinary protein more significantly than single agent.

详细描述

This project is a single-center retrospective cohort study to obtain the biochemical index levels of urinary albumin creatinine ratio, urinary protein creatinine ratio, blood renal function, blood lipids, and blood glucose at the immediate, 3rd, 6th, and 12th month of cohort inclusion in each group of patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age greater than or equal to 18 years
  • Clinical diagnosis of type 2 diabetes mellitus
  • Immediate urine albumin creatinine ratio greater than 30mg/g
  • Signed informed consent and available for follow-up

排除标准

  • severe renal insufficiency, i.e. eGFR ≤ 30ml/min/1.75m2
  • clinical diagnosis of various acute and chronic urinary tract infections
  • combined with various serious infectious diseases
  • combined with acute complications of diabetes mellitus
  • end-stage malignancy
  • pregnancy and lactation

结局指标

主要结局

urinary protein changes

时间窗: 2023.03-2024.03

to determine whether the combination of SGLT2i and ARNI in type 2 diabetic patients with combined albuminuria could reduce urinary protein more significantly than single agent.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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