Insulin Regulation and Severity of Severe Acute Respiratory Syndrome COVID-19 Infection
NCT ID: NCT05897528
Last Updated: 2023-06-09
Study Results
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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COMPLETED
589 participants
OBSERVATIONAL
2021-10-14
2022-12-30
Brief Summary
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Detailed Description
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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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Study Design
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COHORT
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
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
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
Eligibility Criteria
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Inclusion Criteria
* COVID-19 confirmed by laboratory testing (ICD10 U07.1)
* Pneumonia due to COVID-19 (ICD10 J12.82)
* Diagnosis of Diabetes Mellitus
Exclusion Criteria
* COVID in pregnancy
18 Years
99 Years
ALL
No
Sponsors
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Arrowhead Regional Medical Center
OTHER
Responsible Party
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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
Countries
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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.
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.
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.
Other Identifiers
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21-35
Identifier Type: -
Identifier Source: org_study_id
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