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临床试验/NCT07708610
NCT07708610尚未招募不适用

Preadmission GLP-1 Receptor Agonist Plus SGLT2 Inhibitor Use and Early Outcomes After Pneumonia Hospitalization in Adults With Type 2 Diabetes: A Target Trial Emulation

Chung Shan Medical University1 个研究点 分布在 1 个国家目标入组 71,775 人开始时间: 2026年7月31日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
71,775
试验地点
1
主要终点
Composite outcome (all-cause mortality, invasive mechanical ventilation, or renal replacement therapy)

研究概览

简要总结

This retrospective observational target-trial emulation uses electronic health record data from the TriNetX US Collaborative Network to compare preadmission glucose-lowering treatment strategies in adults with type 2 diabetes hospitalized with pneumonia. Time zero is the date of the index pneumonia admission. The study compares patients with evidence of prescriptions for both a GLP-1 receptor agonist and an SGLT2 inhibitor in the year before admission with patients prescribed a GLP-1 receptor agonist alone, an SGLT2 inhibitor alone, or usual care. Usual care includes metformin, sulfonylureas, or DPP-4 inhibitors without either study class. The primary outcome is a composite of all-cause death, invasive mechanical ventilation, or renal replacement therapy within 30 days of admission, with the individual components and 12-month mortality, major adverse cardiovascular events, and major adverse kidney events also evaluated. Propensity-score methods are used to reduce bias from nonrandom treatment selection.

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

  • Adults aged 18 years or older.
  • Type 2 diabetes mellitus
  • Hospitalization with pneumonia during the study period, serving as the index admission
  • Prescription of a GLP-1 receptor agonist, an SGLT2 inhibitor, or usual-care glucose-lowering therapy in the year before the index admission
  • No GLP-1 receptor agonist or SGLT2 inhibitor prescription in the 6 months before the first qualifying prescription

排除标准

  • Type 1 diabetes mellitus, or other specified diabetes types that are not type 2 diabetes
  • Human immunodeficiency virus infection
  • Bariatric surgery
  • Solid-organ transplantation
  • Pneumonia hospitalization, invasive mechanical ventilation, or renal replacement therapy in the year before the index admission
  • End-stage kidney disease, dialysis dependence, ventilator dependence, or tracheostomy status
  • Metastatic malignancy, lung cancer, or palliative care
  • Viral pneumonia, influenza with pneumonia, or COVID-19 around the index admission
  • Acute cardiovascular event in the 6 months before the index admission

结局指标

主要结局

Composite outcome (all-cause mortality, invasive mechanical ventilation, or renal replacement therapy)

时间窗: Within 30 days after the index pneumonia admission

次要结局

  • All-cause mortality(Within 30 days after the index pneumonia admission)
  • Invasive mechanical ventilation(Within 30 days after the index pneumonia admission)
  • Renal replacement therapy(Within 30 days after the index pneumonia admission)
  • Composite outcome (all-cause mortality, major adverse cardiovascular events, or major adverse kidney events)(Through 12 months after the index pneumonia admission)
  • All-cause mortality(Through 12 months after the index pneumonia admission)
  • Major adverse cardiovascular events(Through 12 months after the index pneumonia admission)
  • Major adverse kidney events(Through 12 months after the index pneumonia admission)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yu-Nan Huang

Assistant Professor/Research Fellow

Chung Shan Medical University

研究点 (1)

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