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

NCT ID: NCT05083013

Last Updated: 2021-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-01

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Reverse transcription polymerase chain reaction (RT-PCR)

Intervention Type DIAGNOSTIC_TEST

For SARS Corona Virus 2 (COV2) confirmation

Glycated haemoglobin (HbA1C)

Intervention Type 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

High Resolution Computed Tomography (HRCT)

Intervention Type RADIATION

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

Routine Laboratory investigations

Intervention Type DIAGNOSTIC_TEST

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

Random Blood Sugar (RBS)

Intervention Type DIAGNOSTIC_TEST

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.

Reverse transcription polymerase chain reaction (RT-PCR)

Intervention Type DIAGNOSTIC_TEST

For SARS Corona Virus 2 (COV2) confirmation

Glycated haemoglobin (HbA1C)

Intervention Type 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

High Resolution Computed Tomography (HRCT)

Intervention Type RADIATION

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

Routine Laboratory investigations

Intervention Type DIAGNOSTIC_TEST

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

Random Blood Sugar (RBS)

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Reverse transcription polymerase chain reaction (RT-PCR)

For SARS Corona Virus 2 (COV2) confirmation

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

High Resolution Computed Tomography (HRCT)

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

Intervention Type RADIATION

Routine Laboratory investigations

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

Intervention Type DIAGNOSTIC_TEST

Random Blood Sugar (RBS)

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Reverse transcription polymerase chain reaction Glycated haemoglobin High Resolution Computed Tomography

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Martina Saad Lamey

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martina S. Lamey Eskander, MBBCH.

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

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Raafat T. Ebrahem, MD

Role: CONTACT

+201006155517

Ahmed M. Azozz, MD

Role: CONTACT

+201002163907

References

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Other Identifiers

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outcomes of DM in COVID-19

Identifier Type: -

Identifier Source: org_study_id