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

NCT ID: NCT05897528

Last Updated: 2023-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

589 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-14

Study Completion Date

2022-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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COVID-19 Diabetes Mellitus COVID-19 Pneumonia COVID-19 Respiratory Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Diabetes Mellitus Positive Group

All patient that have a diagnosis of diabetes mellitus and COVID-19 Diagnosis

No Intervention

Intervention Type OTHER

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.

No Intervention

Intervention Type OTHER

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

Interventions

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No Intervention

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arrowhead Regional Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexander Phan, MD

Role: PRINCIPAL_INVESTIGATOR

Arrowhead Regional Medical Center

Locations

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Arrowhead Regional Medical Center

Colton, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 32408118 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32578683 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32804317 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32687793 (View on PubMed)

Other Identifiers

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21-35

Identifier Type: -

Identifier Source: org_study_id

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