Clinical trial NCT05083013: Diabetes In Relation to Hospitalized COVID-19 Patents At Assiut University Hospital
Official title: Outcomes of Diabetes In Hospitalized COVID-19 Patients At Assiut University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus
COVID-19
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-10-19
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Mortality rates
timeFrame: up to 1 year
measure: Hospital stays
timeFrame: up to 1 year
measure: Need for ICU admission
timeFrame: up to 1 year
measure: Need for ventilatory support
timeFrame: up to 1 year
Secondary outcomes:
measure: Glycemic control
timeFrame: up to 1 year
measure: Newly onset DM will appear among non-diabetic patients
timeFrame: up to 1 year
measure: Acute complications of diabetes
timeFrame: up to 1 year
measure: Exacerbation of chronic complications of diabetes
timeFrame: up to 1 year
measure: Changes of diabetes management plan
timeFrame: up to 1 year
measure: Incidence of other complications
timeFrame: up to 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Martina S. Lamey Eskander, MBBCH.
role: PRINCIPAL_INVESTIGATOR
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