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临床试验/NCT05897528
NCT05897528已完成不适用

Impaired Insulin Regulation Determining Severity of Severe Acute Respiratory Syndrome COVID-19 Infection Confounded by Ethnicity

Arrowhead Regional Medical Center1 个研究点 分布在 1 个国家目标入组 589 人开始时间: 2021年10月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
589
试验地点
1
主要终点
Hospital Mortality

研究概览

简要总结

The Coronavirus Disease of 2019 (COVID-19) pandemic has caused an international healthcare crisis and produced a large healthcare burden. Diabetes mellitus is a common disease that can be controlled via pharmacologic agents; however, many patients have poor glycemic control, leading to disease-related complications. Diabetes mellitus has been reported in the literature to be associated with increasing morbidity and mortality in COVID-19 patients, and some hypothesize that this is due to insulin dysregulation propagating a pro-inflammatory state. The investigators aim to contribute to the growing body of literature that assesses the associations between glucose homeostasis and COVID-19 disease severity and mortality.

详细描述

The Coronavirus Disease of 2019 (COVID-19) is caused by an infection from the severe acute respiratory syndrome coronavirus 2, and the first case in the United States was documented on January 31, 2020. Severe acute respiratory syndrome coronavirus 2 is a RNA virus that has 82% homology with severe acute respiratory syndrome coronavirus 2, which caused a pandemic in 2003. Severe acute respiratory syndrome coronavirus 2 enters cells via the angiotensin converting enzyme 2 (ACE2) receptor, which is primarily expressed in the lung. COVID-19 has led to a worldwide pandemic, with over six million deaths attributed to the virus, according to the World Health Organization. This emerging infection has caused an international healthcare crisis with a significant burden on healthcare workers.

Advanced age, male sex, cardiovascular disease, and diabetes mellitus are known to be associated with increasing risk for COVID-19 severity and mortality. Diabetes mellitus is a common disease that affects the general population by disrupting glucose homeostasis. Impaired glycemic control produces a state of hyperglycemia, which leads to multi-organ injury via a chronic, pathophysiologic inflammatory state. Early retrospective studies demonstrated the association of insulin dysregulation with COVID-19 disease severity and mortality. With more data availability and time, many studies have been conducted to better characterize the relationships between hyperglycemia and elevated hemoglobin A1c (HbA1c) with COVID-19 disease susceptibility, severity, and mortality.

Through this retrospective analysis, the investigators investigate the associations of HbA1c levels and hyperglycemia with COVID-19 mortality and disease severity.

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • At least 18 years of age
  • COVID-19 confirmed by laboratory testing (ICD10 U07.1)
  • Pneumonia due to COVID-19 (ICD10 J12.82)
  • Diagnosis of Diabetes Mellitus

排除标准

  • All patients under the age of 18
  • COVID in pregnancy

结局指标

主要结局

Hospital Mortality

时间窗: 30 days

Survival within the first 30 days

Length of time spent intubated on a ventilator

时间窗: 30 days

The time spent intubated on a ventilator in days.

Length of hospital stay

时间窗: Total time frame was 360 days

The time spent hospitalized in days.

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 (1)

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