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CompletedNCT05477394COVID19Updated Jul 28, 2022

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

An observational study in COVID-19, sponsored by Ain Shams University. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2022-07-28.

Sponsored by Ain Shams University · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
90
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Study 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.

Read the 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.

02

Conditions studied

  • COVID-19

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03

In context

Metabolic Syndrome

1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.

This study's enrollment of 90 is below the median of 200 across 458 observational studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,879 studies on the registry; 424 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sampling method
Non-probability sample

Study population

  • critical SARS-COV-2 patients.
  • 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 witout metabolic syndrome .

Sample Size: 45 patients for each group

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

Exclusion Criteria:

    1. Patients below 21 years old. 2. Psychiatric disorders. 3. Lack of consent.
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
90 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

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

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

    Time frame: 6 months

Secondary outcomes

  1. number of Covid patients who needed mechanical ventilation.

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

    Time frame: 6 months

07

Study locations

1 site
  • Ain Shams University
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: Yes — we will share data which prove that covid patient with metabolic syndrome has a bad prognosis during his treatment

Supporting information: Study protocol, Sap, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05477394
Lead sponsor
Ain Shams University
Responsible party
Sponsor
First posted
Jul 28, 2022
Start date
Apr 1, 2021
Primary completion
Dec 30, 2021
Completion
Jan 30, 2022
Last update
Jul 28, 2022

Study contacts

amr mo hilal
study director · Ain Shams University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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