Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05477394 |
| Other study ID # |
obsevational |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2021 |
| Est. completion date |
January 30, 2022 |
Study information
| Verified date |
July 2022 |
| Source |
Ain Shams University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
