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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05083013
Enrollment
160
Registered
2021-10-19
Start date
2021-11-01
Completion date
2022-12-31
Last updated
2021-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, Diabetes Mellitus

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.

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.

Interventions

DIAGNOSTIC_TESTReverse transcription polymerase chain reaction (RT-PCR)

For SARS Corona Virus 2 (COV2) confirmation

DIAGNOSTIC_TESTGlycated 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

RADIATIONHigh Resolution Computed Tomography (HRCT)

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

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

DIAGNOSTIC_TESTRandom Blood Sugar (RBS)

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Mortality ratesup to 1 yearmortality rate among diabetic and non diabetic COVID-19 patients
Hospital staysup to 1 yearfor how long patients admitted to hospital
Need for ICU admissionup to 1 yearwho will need ICU admission during patient hospitalization
Need for ventilatory supportup to 1 yearwho will need for ventilatory support (Non-Invasive ventilation (NIV), High Flow Nasal Cannula (HFNC) and Invasive Mechanical Ventilation (IMV).

Secondary

MeasureTime frameDescription
Changes of diabetes management planup to 1 yearwho 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
Glycemic controlup to 1 yearmonitoring of glycemic control among patient groups
Incidence of other complicationsup to 1 yearas hypertension renal and liver diseases
Newly onset DM will appear among non-diabetic patientsup to 1 yearwho will develop DM among non-diabetic group
Acute complications of diabetesup to 1 yearas hypoglycaemia, diabetic ketoacidosis and hyperosmolar nonketotic coma
Exacerbation of chronic complications of diabetesup to 1 yearas diabetic retinopathy, nephropathy and neuropathy

Contacts

Primary ContactRaafat T. Ebrahem, MD
raafatelsokkary1@gmail.com+201006155517
Backup ContactAhmed M. Azozz, MD
ahmedmetwally@aun.edu.eg+201002163907

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026