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NCT Number: NCT05897528

Insulin Regulation and Severity of Severe Acute Respiratory Syndrome COVID-19 Infection

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.

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Key information

Conditions

COVID-19 COVID-19 Pneumonia COVID-19 Respiratory Infection Coronaviridae Infections Coronavirus Infections Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Infections Lung Diseases Metabolic Diseases Nidovirales Infections Nutritional and Metabolic Diseases Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Arrowhead Regional Medical Center

Colton, California, 92324, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

No intervention

Other

Difference in outcomes in patients with COVID-19 diagnosis and diabetes mellitus groups

Primary outcomes

  1. Length of hospital stay

    Time frame: Total time frame was 360 days

    The time spent hospitalized in days.

  2. Length of time spent intubated on a ventilator

    Time frame: 30 days

    The time spent intubated on a ventilator in days.

  3. Hospital Mortality

    Time frame: 30 days

    Survival within the first 30 days

Sponsors and collaborators

Lead sponsor

Arrowhead Regional Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 9, 2023
Registry last updated
Jun 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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