Diabetes In Relation to Hospitalized COVID-19 Patents At Assiut University Hospital
- Conditions
- COVID-19Diabetes Mellitus
- Interventions
- Diagnostic Test: Reverse transcription polymerase chain reaction (RT-PCR)Diagnostic Test: Glycated haemoglobin (HbA1C)Radiation: High Resolution Computed Tomography (HRCT)Diagnostic Test: Routine Laboratory investigationsDiagnostic Test: Random Blood Sugar (RBS)
- Registration Number
- NCT05083013
- Lead Sponsor
- Assiut University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 160
- Cases aged 18 years and over.
- Cases diagnosed as COVID-19 positive.
- Cases admitted to Assiut University Hospitals.
- Age less than 18 years.
- Outpatient management (even in confirmed cases of COVID-19).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description COVID-19 with DM High Resolution Computed Tomography (HRCT) 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. COVID-19 with DM Random Blood Sugar (RBS) 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. COVID-19 with DM Reverse transcription polymerase chain reaction (RT-PCR) 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. COVID-19 with DM Routine Laboratory investigations 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. COVID-19 without DM Reverse transcription polymerase chain reaction (RT-PCR) 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. COVID-19 without DM Glycated haemoglobin (HbA1C) 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. COVID-19 with DM Glycated haemoglobin (HbA1C) 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. COVID-19 without DM High Resolution Computed Tomography (HRCT) 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. COVID-19 without DM Random Blood Sugar (RBS) 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. COVID-19 without DM Routine Laboratory investigations 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.
- Primary Outcome Measures
Name Time Method Mortality rates up to 1 year mortality rate among diabetic and non diabetic COVID-19 patients
Need for ICU admission up to 1 year who will need ICU admission during patient hospitalization
Hospital stays up to 1 year for how long patients admitted to hospital
Need for ventilatory support up to 1 year who will need for ventilatory support (Non-Invasive ventilation (NIV), High Flow Nasal Cannula (HFNC) and Invasive Mechanical Ventilation (IMV).
- Secondary Outcome Measures
Name Time Method Exacerbation of chronic complications of diabetes up to 1 year as diabetic retinopathy, nephropathy and neuropathy
Incidence of other complications up to 1 year as hypertension renal and liver diseases
Glycemic control up to 1 year monitoring of glycemic control among patient groups
Newly onset DM will appear among non-diabetic patients up to 1 year who will develop DM among non-diabetic group
Acute complications of diabetes up to 1 year as hypoglycaemia, diabetic ketoacidosis and hyperosmolar nonketotic coma
Changes of diabetes management plan up to 1 year 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