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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05897528
• Other study ID #: 21-35
• Status: Completed
• Start date: October 14, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: May 2023
• Source: Arrowhead Regional Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 589
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• COVID-19 Pneumonia
• Diabetes Mellitus
• Infections
• Respiratory Tract Infections
• Severe Acute Respiratory Syndrome

Intervention

Other:
• No Intervention
Difference in outcomes in patients with COVID-19 diagnosis and diabetes mellitus groups

Locations

Country	Name	City	State
United States	Arrowhead Regional Medical Center	Colton	California

Sponsors (1)

Lead Sponsor	Collaborator
Arrowhead Regional Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospital stay	The time spent hospitalized in days.	Total time frame was 360 days
Primary	Length of time spent intubated on a ventilator	The time spent intubated on a ventilator in days.	30 days
Primary	Hospital Mortality	Survival within the first 30 days	30 days