Diabetes In Relation to Hospitalized COVID-19 Patents At Assiut University Hospital

COVID-19 Clinical Trial

Official title:

Outcomes of Diabetes In Hospitalized COVID-19 Patients At Assiut University Hospital

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05083013
• Other study ID #: outcomes of DM in COVID-19
• Status: Not yet recruiting
• Start date: November 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2021
• Source: Assiut University
• Contact: Raafat T. Ebrahem, MD
• Phone: +201006155517
• Email: raafatelsokkary1[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Coronavirus disease (COVID-19), a global pandemic affecting the whole world and taking the lives of millions. The majority of fatalities occur in the elderly specially in the presence of chronic diseases such as diabetes mellitus (DM), hypertension, obesity, cardiovascular disease, chronic kidney disease and cancer.

Description:

Knowing about the family of coronaviruses is that they are the cause of a variety of well-known diseases affecting humans, ranging from common cold to the Middle East Respiratory Syndrome (MERS) and Acute Severe Respiratory Syndrome (SARS), and now the COVID-19 as a new problematic family member. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: December 31, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Cases aged 18 years and over.
• Cases diagnosed as COVID-19 positive.
• Cases admitted to Assiut University Hospitals.

Exclusion Criteria:

• Age less than 18 years.
• Outpatient management (even in confirmed cases of COVID-19).

Related Conditions & MeSH terms

• COVID-19
• Diabetes Mellitus

Intervention

Diagnostic Test:
• 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

Radiation:
• High Resolution Computed Tomography (HRCT)
with the coronavirus disease 2019 Reporting and Data System (CO-RADS) classification grade 5 for SARS COV2 confirmation

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (10)

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 Lomb — View Citation

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, — View Citation

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 — View Citation

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 Mar 31:e3319. doi: 10.1002/dmrr.3319. [Epub ahead — View Citation

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. pii: S0210-5691(20)30396-X. doi: 10.1016/j.medin.2020.12.001. [Epub a — View Citation

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. Review. — View Citation

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. — View Citation

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 Feb 9:1-6. doi: 10.1007/s13410-021-00930-y. [Epub ahe — View Citation

Prokop M, van Everdingen W, van Rees Vellinga T, Quarles van Ufford H, Stöger 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-RAD — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality rates	mortality rate among diabetic and non diabetic COVID-19 patients	up to 1 year
Primary	Hospital stays	for how long patients admitted to hospital	up to 1 year
Primary	Need for ICU admission	who will need ICU admission during patient hospitalization	up to 1 year
Primary	Need for ventilatory support	who will need for ventilatory support (Non-Invasive ventilation (NIV), High Flow Nasal Cannula (HFNC) and Invasive Mechanical Ventilation (IMV).	up to 1 year
Secondary	Glycemic control	monitoring of glycemic control among patient groups	up to 1 year
Secondary	Newly onset DM will appear among non-diabetic patients	who will develop DM among non-diabetic group	up to 1 year
Secondary	Acute complications of diabetes	as hypoglycaemia, diabetic ketoacidosis and hyperosmolar nonketotic coma	up to 1 year
Secondary	Exacerbation of chronic complications of diabetes	as diabetic retinopathy, nephropathy and neuropathy	up to 1 year
Secondary	Changes of diabetes management plan	who will be shifted from oral to insulin therapy and who will be changed of their insulin regimen or introduction form from subcutaneous to intravenous infusion	up to 1 year
Secondary	Incidence of other complications	as hypertension renal and liver diseases	up to 1 year