Diabetes In Relation to Hospitalized COVID-19 Patents At Assiut University Hospital
NCT ID: NCT05083013
Last Updated: 2021-10-19
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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UNKNOWN
160 participants
OBSERVATIONAL
2021-11-01
2022-12-31
Brief Summary
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Detailed Description
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Regarding DM as a knowing old health problem, it has been found that we can use it in predicting the prognosis of the COVID-19 as admission to intensive care unit, invasive ventilation or even death.
Previous studies confirmed that uncontrolled DM can badly affects innate immunity which considered as the first line of defence mechanism against COVID-19 infection.
In addition, DM has a pro-inflammatory effect through exaggeration of cytokine response which appears clearly through higher results of serum levels of interleukin-6 (IL-6), C-reactive protein and ferritin, this suggests that people with DM are more venerable to cytokine storm which leads to Acute Respiratory Distress Syndrome (ARDS), shock and rapid deterioration of the case.
On the other hand, on looking to previous studies and data collected about the prior SARS outbreak in 2003, which suggested that COVID-19 can lead to worsening of glycemic control in known diabetic patients and above that caused by the stressful nature of a critical illness.
In addition, COVID-19 can lead to increasing insulin resistance specially in patients with type II DM. Also, the medications used in the management of COVID-19 having an indirect role on worsening of blood sugar levels also should be taken in our consideration, Corticosteroids as an example, used in the management of patients having ARDS or sepsis can lead to changes in their glycemic profile.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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COVID-19 with DM
All patients will be screened for diabetes according to history and blood glucose measurements as well as HbA1C.
Accordingly, the patients will be divided into two groups, diabetic and non-diabetic group.
Reverse transcription polymerase chain reaction (RT-PCR)
For SARS Corona Virus 2 (COV2) confirmation
Glycated haemoglobin (HbA1C)
Diabetic patients' group will be categorized according to their glycemic control by using their glycated haemoglobin (HBA1C) into good control, fair control and poor control
High Resolution Computed Tomography (HRCT)
with the coronavirus disease 2019 Reporting and Data System (CO-RADS) classification grade 5 for SARS COV2 confirmation
Routine Laboratory investigations
* Arterial blood gases (ABGs)
* Routine Laboratory investigations (Urea, Creatinine, Liver function tests, Serum Electrolytes, Prothrombin Concentration)
Random Blood Sugar (RBS)
Blood Sugar will be measured before each meal and before bed time during hospitalization.
COVID-19 without DM
All patients will be screened for diabetes according to history and blood glucose measurements as well as HbA1C.
Accordingly, the patients will be divided into two groups, diabetic and non-diabetic group.
Reverse transcription polymerase chain reaction (RT-PCR)
For SARS Corona Virus 2 (COV2) confirmation
Glycated haemoglobin (HbA1C)
Diabetic patients' group will be categorized according to their glycemic control by using their glycated haemoglobin (HBA1C) into good control, fair control and poor control
High Resolution Computed Tomography (HRCT)
with the coronavirus disease 2019 Reporting and Data System (CO-RADS) classification grade 5 for SARS COV2 confirmation
Routine Laboratory investigations
* Arterial blood gases (ABGs)
* Routine Laboratory investigations (Urea, Creatinine, Liver function tests, Serum Electrolytes, Prothrombin Concentration)
Random Blood Sugar (RBS)
Blood Sugar will be measured before each meal and before bed time during hospitalization.
Interventions
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Reverse transcription polymerase chain reaction (RT-PCR)
For SARS Corona Virus 2 (COV2) confirmation
Glycated haemoglobin (HbA1C)
Diabetic patients' group will be categorized according to their glycemic control by using their glycated haemoglobin (HBA1C) into good control, fair control and poor control
High Resolution Computed Tomography (HRCT)
with the coronavirus disease 2019 Reporting and Data System (CO-RADS) classification grade 5 for SARS COV2 confirmation
Routine Laboratory investigations
* Arterial blood gases (ABGs)
* Routine Laboratory investigations (Urea, Creatinine, Liver function tests, Serum Electrolytes, Prothrombin Concentration)
Random Blood Sugar (RBS)
Blood Sugar will be measured before each meal and before bed time during hospitalization.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Cases diagnosed as COVID-19 positive.
* Cases admitted to Assiut University Hospitals.
Exclusion Criteria
* Outpatient management (even in confirmed cases of COVID-19).
18 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Martina Saad Lamey
Principal Investigator
Principal Investigators
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Martina S. Lamey Eskander, MBBCH.
Role: PRINCIPAL_INVESTIGATOR
Assiut University
Central Contacts
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References
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Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.
Grasselli G, Zangrillo A, Zanella A, Antonelli M, Cabrini L, Castelli A, Cereda D, Coluccello A, Foti G, Fumagalli R, Iotti G, Latronico N, Lorini L, Merler S, Natalini G, Piatti A, Ranieri MV, Scandroglio AM, Storti E, Cecconi M, Pesenti A; COVID-19 Lombardy ICU Network. Baseline Characteristics and Outcomes of 1591 Patients Infected With SARS-CoV-2 Admitted to ICUs of the Lombardy Region, Italy. JAMA. 2020 Apr 28;323(16):1574-1581. doi: 10.1001/jama.2020.5394.
Guan WJ, Liang WH, Zhao Y, Liang HR, Chen ZS, Li YM, Liu XQ, Chen RC, Tang CL, Wang T, Ou CQ, Li L, Chen PY, Sang L, Wang W, Li JF, Li CC, Ou LM, Cheng B, Xiong S, Ni ZY, Xiang J, Hu Y, Liu L, Shan H, Lei CL, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Cheng LL, Ye F, Li SY, Zheng JP, Zhang NF, Zhong NS, He JX; China Medical Treatment Expert Group for COVID-19. Comorbidity and its impact on 1590 patients with COVID-19 in China: a nationwide analysis. Eur Respir J. 2020 May 14;55(5):2000547. doi: 10.1183/13993003.00547-2020. Print 2020 May.
Jafar N, Edriss H, Nugent K. The Effect of Short-Term Hyperglycemia on the Innate Immune System. Am J Med Sci. 2016 Feb;351(2):201-11. doi: 10.1016/j.amjms.2015.11.011.
Guo W, Li M, Dong Y, Zhou H, Zhang Z, Tian C, Qin R, Wang H, Shen Y, Du K, Zhao L, Fan H, Luo S, Hu D. Diabetes is a risk factor for the progression and prognosis of COVID-19. Diabetes Metab Res Rev. 2020 Oct;36(7):e3319. doi: 10.1002/dmrr.3319. Epub 2020 Apr 7.
Kassir R. Risk of COVID-19 for patients with obesity. Obes Rev. 2020 Jun;21(6):e13034. doi: 10.1111/obr.13034. Epub 2020 Apr 13. No abstract available.
Huespe I, Carboni Bisso I, Di Stefano S, Terrasa S, Gemelli NA, Las Heras M. COVID-19 Severity Index: A predictive score for hospitalized patients. Med Intensiva (Engl Ed). 2020 Dec 29;46(2):98-101. doi: 10.1016/j.medin.2020.12.001. Online ahead of print. No abstract available.
Prokop M, van Everdingen W, van Rees Vellinga T, Quarles van Ufford H, Stoger L, Beenen L, Geurts B, Gietema H, Krdzalic J, Schaefer-Prokop C, van Ginneken B, Brink M; COVID-19 Standardized Reporting Working Group of the Dutch Radiological Society. CO-RADS: A Categorical CT Assessment Scheme for Patients Suspected of Having COVID-19-Definition and Evaluation. Radiology. 2020 Aug;296(2):E97-E104. doi: 10.1148/radiol.2020201473. Epub 2020 Apr 27.
Moftakhar L, Moftakhar P, Piraee E, Ghaem H, Valipour A, Azarbakhsh H. Epidemiological characteristics and outcomes of COVID-19 in diabetic versus non-diabetic patients. Int J Diabetes Dev Ctries. 2021 Jul;41(3):383-388. doi: 10.1007/s13410-021-00930-y. Epub 2021 Feb 9.
Other Identifiers
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outcomes of DM in COVID-19
Identifier Type: -
Identifier Source: org_study_id