Insulin Regulation and Severity of Severe Acute Respiratory Syndrome COVID-19 Infection
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Diabetes Mellitus Positive Group All patient that have a diagnosis of diabetes mellitus and COVID-19 Diagnosis |
Other: No Intervention
Difference in outcomes in patients with COVID-19 diagnosis and diabetes mellitus groups
|
| Diabetes Mellitus Negative Group All patient that do not have a diagnosis of diabetes mellitus but do have a diagnosis of COVID-19. |
Other: No Intervention
Difference in outcomes in patients with COVID-19 diagnosis and diabetes mellitus groups
|
Outcome Measures
Primary Outcome Measures
- Length of hospital stay [Total time frame was 360 days]
The time spent hospitalized in days.
- Length of time spent intubated on a ventilator [30 days]
The time spent intubated on a ventilator in days.
- Hospital Mortality [30 days]
Survival within the first 30 days
Eligibility Criteria
Criteria
Inclusion Criteria:
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At least 18 years of age
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COVID-19 confirmed by laboratory testing (ICD10 U07.1)
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Pneumonia due to COVID-19 (ICD10 J12.82)
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Diagnosis of Diabetes Mellitus
Exclusion Criteria:
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All patients under the age of 18
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COVID in pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Arrowhead Regional Medical Center | Colton | California | United States | 92324 |
Sponsors and Collaborators
- Arrowhead Regional Medical Center
Investigators
- Principal Investigator: Alexander Phan, MD, Arrowhead Regional Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
- Apicella M, Campopiano MC, Mantuano M, Mazoni L, Coppelli A, Del Prato S. COVID-19 in people with diabetes: understanding the reasons for worse outcomes. Lancet Diabetes Endocrinol. 2020 Sep;8(9):782-792. doi: 10.1016/S2213-8587(20)30238-2. Epub 2020 Jul 17. Erratum In: Lancet Diabetes Endocrinol. 2020 Oct;8(10):e5. Lancet Diabetes Endocrinol. 2020 Nov;8(11):e6.
- Espinosa OA, Zanetti ADS, Antunes EF, Longhi FG, Matos TA, Battaglini PF. Prevalence of comorbidities in patients and mortality cases affected by SARS-CoV2: a systematic review and meta-analysis. Rev Inst Med Trop Sao Paulo. 2020 Jun 22;62:e43. doi: 10.1590/S1678-9946202062043. eCollection 2020.
- Fox T, Ruddiman K, Lo KB, Peterson E, DeJoy R 3rd, Salacup G, Pelayo J, Bhargav R, Gul F, Albano J, Azmaiparashvili Z, Anastasopoulou C, Patarroyo-Aponte G. The relationship between diabetes and clinical outcomes in COVID-19: a single-center retrospective analysis. Acta Diabetol. 2021 Jan;58(1):33-38. doi: 10.1007/s00592-020-01592-8. Epub 2020 Aug 17.
- Kumar A, Arora A, Sharma P, Anikhindi SA, Bansal N, Singla V, Khare S, Srivastava A. Is diabetes mellitus associated with mortality and severity of COVID-19? A meta-analysis. Diabetes Metab Syndr. 2020 Jul-Aug;14(4):535-545. doi: 10.1016/j.dsx.2020.04.044. Epub 2020 May 6.
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