COVID19: Metabolic Syndrome as Prognostic Factor for Outcome of Sever SARS-COV-2 Cases.

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT05477394
Collaborator
(none)
90
1
10
9

Study Details

Study Description

Brief Summary

SARS-COV-2 crisis is a severe public health concern in the world. It is now well recognized that older age, diabetes mellitus, obesity (BMI > 30 kg/m2), and hypertension increase the risk of complications and death in SARS-COV-2 patients.

This study will describe the spectrum of clinical features, the likely pathophysiologic mechanisms, and potential implications for the management of metabolic syndrome in SARS-COV-2 patients.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    SARS-COV-2 (Coronavirus Disease-2019), a disease caused by the coronavirus. SARS-CoV-2 (Sever Acute Respiratory Syndrome-Coronavirus-2) has emerged as a rapidly spreading communicable disease affecting more than 100 countries across the globe at present.

    The disease is primarily spread through large respiratory droplets, though the possibility of other routes of transmission cannot be ruled out, as the virus has been found in stool and urine of affected individuals.

    The disease severity has varied from mild self-limiting flu-like illness to fulminant pneumonia, respiratory failure and death. Several risk groups have been identified as being at higher risk of developing a more severe form of the disease and, subsequently, have higher mortality. In particular, cardiovascular diseases, hypertension, chronic respiratory diseases, metabolic syndrome (MS), and diabetes mellitus (DM) appear to play an important role in developing a more severe form of the disease with several complications.

    Metabolic syndrome is a constellation of cardiovascular risk factors that include abdominal obesity, elevated blood pressure, dysglycemia, atherogenic dyslipidemia, pro-thrombotic state, and pro-inflammatory state).

    Clinically, metabolic syndrome is defined as the presence of 3 or more of the following factors: increased waist circumference (population and country-specific cutoff), hypertriglyceridemia (>150 mg/dL or on treatment for hypertriglyceridemia), elevated blood pressure (systolic . 130 and/or diastolic . 85 mm Hg or with a history of hypertension on treatment), reduced high-density lipoprotein cholesterol (<40 mg/dL in males; <50 mg/dL in females), and dysglycemia (.100 mg/dL or on treatment for hyperglycemia)

    . Components of metabolic syndrome such as hypertension, type 2 diabetes mellitus (T2DM), and obesity are highly prevalent and significantly increase the risk of hospitalization and mortality in SARS-COV-2 patients.

    The pathophysiologic mechanisms for these observations have not been fully explained. A critical interaction between SARS-CoV-2 and the angiotensin-converting enzyme 2 (ACE2) facilitates viral entry into the host cell. ACE2 is expressed in pancreatic islets, vascular endothelium, and adipose tissue, and the SARS-CoV-2 -ACE2 interaction in these tissues, along with other factors governs the spectrum and the severity of clinical manifestations among SARS-COV-2 patients with metabolic syndrome.

    Moreover, the pro-inflammatory milieu observed in patients with metabolic syndrome may contribute toward SARS-COV-2-mediated host immune dysregulation, including suboptimal immune responses, hyper inflammation, micro-vascular dysfunction, and thrombosis.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    90 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Metabolic Syndrome as a Prognostic Factor for Outcome of Sever SARS-COV-2 Cases.
    Actual Study Start Date :
    Apr 1, 2021
    Actual Primary Completion Date :
    Dec 30, 2021
    Actual Study Completion Date :
    Jan 30, 2022

    Outcome Measures

    Primary Outcome Measures

    1. The period of time that Covid patients spent in intensive care and its outcome. [6 months]

      We note whether metabolic syndrome in cases of Covid is related to the length of stay in the hospital or not.

    Secondary Outcome Measures

    1. number of Covid patients who needed mechanical ventilation. [6 months]

      We note whether metabolic syndrome in cases of Covid is related to the need of mechanical ventilation or not.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • patients admitted to for Sever Pneumonic COVID-19 infection with a confirmed positive RT-PCR for COVID-19 and chest computed tomography that is divided into two groups.

    • Group one is critical COVID patients with metabolic syndrome .

    • Group two is critical COVID without metabolic syndrome .

    1. Age 21-50 years old.

    2. Sex both sexes.

    3. Patients having metabolic syndrome defined before who have:

    • Diabetes mellitus.

    • Hypertension.

    • Obesity( BMI < 30 kg/m2)

    Exclusion Criteria:
      1. Patients below 21 years old. 2. Psychiatric disorders. 3. Lack of consent.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ain Shams University Cairo Egypt

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    • Study Director: amr mo hilal, Ain Shams University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT05477394
    Other Study ID Numbers:
    • obsevational
    First Posted:
    Jul 28, 2022
    Last Update Posted:
    Jul 28, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 28, 2022