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

NCT05083013 | Unknown

• 1 other identifier: outcomes of DM in COVID-19
• Study Type: observational
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Diabetes Mellitus; COVID-19

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Glycemic control

  up to 1 year

• Newly onset DM will appear among non-diabetic patients

  up to 1 year

• Acute complications of diabetes

  up to 1 year

• Exacerbation of chronic complications of diabetes

  up to 1 year

• Changes of diabetes management plan

  up to 1 year

Study Arms (2)

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); Diagnostic Test: Glycated haemoglobin (HbA1C); Radiation: High Resolution Computed Tomography (HRCT); Diagnostic Test: Routine Laboratory investigations; Diagnostic Test: Random Blood Sugar (RBS)

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); Diagnostic Test: Glycated haemoglobin (HbA1C); Radiation: High Resolution Computed Tomography (HRCT); Diagnostic Test: Routine Laboratory investigations; Diagnostic Test: Random Blood Sugar (RBS)

Interventions

Reverse transcription polymerase chain reaction (RT-PCR) DIAGNOSTIC_TEST

For SARS Corona Virus 2 (COV2) confirmation

Also known as: Reverse transcription polymerase chain reaction

COVID-19 with DM; COVID-19 without DM

Glycated haemoglobin (HbA1C) DIAGNOSTIC_TEST

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

Also known as: Glycated haemoglobin

COVID-19 with DM; COVID-19 without DM

High Resolution Computed Tomography (HRCT) RADIATION

with the coronavirus disease 2019 Reporting and Data System (CO-RADS) classification grade 5 for SARS COV2 confirmation

Also known as: High Resolution Computed Tomography

COVID-19 with DM; COVID-19 without DM

Routine Laboratory investigations DIAGNOSTIC_TEST

* Arterial blood gases (ABGs) * Routine Laboratory investigations (Urea, Creatinine, Liver function tests, Serum Electrolytes, Prothrombin Concentration)

COVID-19 with DM; COVID-19 without DM

Random Blood Sugar (RBS) DIAGNOSTIC_TEST

Blood Sugar will be measured before each meal and before bed time during hospitalization.

COVID-19 with DM; COVID-19 without DM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (10)

• 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.

  PMID: 32109013 RESULT

• 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.

  PMID: 32171076 RESULT

• 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.

  PMID: 32250385 RESULT

• 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.

  PMID: 32217650 RESULT

• 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.

  PMID: 26897277 RESULT

• 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.

  PMID: 32233013 RESULT

• 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.

  PMID: 32281287 RESULT

• 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.

  PMID: 33478781 RESULT

• 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.

  PMID: 32339082 RESULT

• 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.

  PMID: 33584062 RESULT

MeSH Terms

Conditions

Diabetes Mellitus; COVID-19

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Martina S. Lamey Eskander, MBBCH.

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raafat T. Ebrahem, MD

CONTACT

+201006155517; raafatelsokkary1@gmail.com

Ahmed M. Azozz, MD

CONTACT

+201002163907; ahmedmetwally@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 10, 2021
• First Posted: October 19, 2021
• Study Start: November 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: December 31, 2022
• Last Updated: October 19, 2021

Record last verified: 2021-10