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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: COVID-19; Diabetes Mellitus
• Intervention / Treatment: Diagnostic test: Reverse transcription polymerase chain reaction (RT-PCR); Diagnostic test: Glycated haemoglobin (HbA1C); Radiation: High Resolution Computed Tomography (HRCT); Diagnostic test: Routine Laboratory investigations; Diagnostic test: Random Blood Sugar (RBS)

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 160

Contacts and Locations

• Study Contact: Name: Raafat T. Ebrahem, MD; Phone Number: +201006155517; Email: raafatelsokkary1@gmail.com
• Study Contact Backup: Name: Ahmed M. Azozz, MD; Phone Number: +201002163907; Email: ahmedmetwally@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients admitted to Assiut University Hospital from the 1st of Oct. 2021 to 1st of Oct. 2022 with confirmed COVID-19 infection, will be included, based on WHO case definitions of COVID-19 All patients will be surveyed and scored by the criteria of COVID-19 severity index, and accordingly categorized into low, moderate, high and critically ill cases All patients will be screened for DM 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.

Diabetic patients' group will be categorized according to their glycemic control by using their glycated hemoglobin (HBA1C) used to determine their past two to three-month glycemic control, into good control, fair control and poor control

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: Reverse transcription polymerase chain reaction (RT-PCR); For SARS Corona Virus 2 (COV2) confirmation; Other Names: Reverse transcription polymerase chain reaction; Diagnostic test: 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; Other Names: Glycated haemoglobin; Radiation: High Resolution Computed Tomography (HRCT); with the coronavirus disease 2019 Reporting and Data System (CO-RADS) classification grade 5 for SARS COV2 confirmation; Other Names: High Resolution Computed Tomography; Diagnostic test: Routine Laboratory investigations; Arterial blood gases (ABGs); Routine Laboratory investigations (Urea, Creatinine, Liver function tests, Serum Electrolytes, Prothrombin Concentration); Diagnostic test: 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.	Diagnostic test: Reverse transcription polymerase chain reaction (RT-PCR); For SARS Corona Virus 2 (COV2) confirmation; Other Names: Reverse transcription polymerase chain reaction; Diagnostic test: 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; Other Names: Glycated haemoglobin; Radiation: High Resolution Computed Tomography (HRCT); with the coronavirus disease 2019 Reporting and Data System (CO-RADS) classification grade 5 for SARS COV2 confirmation; Other Names: High Resolution Computed Tomography; Diagnostic test: Routine Laboratory investigations; Arterial blood gases (ABGs); Routine Laboratory investigations (Urea, Creatinine, Liver function tests, Serum Electrolytes, Prothrombin Concentration); Diagnostic test: Random Blood Sugar (RBS); Blood Sugar will be measured before each meal and before bed time during hospitalization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality rates	mortality rate among diabetic and non diabetic COVID-19 patients	up to 1 year
Hospital stays	for how long patients admitted to hospital	up to 1 year
Need for ICU admission	who will need ICU admission during patient hospitalization	up to 1 year
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic control	monitoring of glycemic control among patient groups	up to 1 year
Newly onset DM will appear among non-diabetic patients	who will develop DM among non-diabetic group	up to 1 year
Acute complications of diabetes	as hypoglycaemia, diabetic ketoacidosis and hyperosmolar nonketotic coma	up to 1 year
Exacerbation of chronic complications of diabetes	as diabetic retinopathy, nephropathy and neuropathy	up to 1 year
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
Incidence of other complications	as hypertension renal and liver diseases	up to 1 year

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Martina S. Lamey Eskander, MBBCH., Assiut University

Publications and helpful links

General Publications

• 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. Erratum In: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.
• 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.
• 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. Erratum In: JAMA. 2021 May 25;325(20):2120.
• 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.
• 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.
• 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 Mar 31;36(7):e3319. doi: 10.1002/dmrr.3319. Online ahead of print.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: October 10, 2021
• First Submitted That Met QC Criteria: October 16, 2021
• First Posted (Actual): October 19, 2021

Study Record Updates

• Last Update Posted (Actual): October 19, 2021
• Last Update Submitted That Met QC Criteria: October 16, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Endocrine System Diseases; COVID-19; Diabetes Mellitus; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Chrysarobin
• Other Study ID Numbers: outcomes of DM in COVID-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No