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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04766294
Other study ID # Soh-Med-21-02-20
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 25, 2020
Est. completion date April 1, 2021

Study information

Verified date June 2021
Source Sohag University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is aiming to find the relation between the severity of COVID-19 in diabetic and obese patients and the high serum levels of matrix metalloproteinase-7 (MMP-7),matrix metalloproteinase-9 (MMP-9), TGF-β and PDGF Macrophage Activation Markers


Description:

Acute respiratory distress syndrome (ARDS) commonly occurs in COVID-19 patients who are diabetic and obese, ARDS is characterized by inflammation and pulmonary fibrosis mediated by cytokines and biomarkers released from activated alveolar macrophages, also cytokine storm may occurs leading to multiple organ failure. These sequelae of COVID-19 disease in obese and diabetic patients are attributed to elevated plasma lipopolysaccharide which is the main activator of M1 and M2 macrophages. chronic activation of macrophages leads to production of profibrotic markers as transforming growth factor-β (TGF-β), platelet-derived growth factor (PDGF), matrix metalloproteinase-7 (MMP7) and matrix metalloproteinase-9 (MMP9) which promote fibrogenesis. In this research, we measure circulatory alveolar macrophage activation markers in COVID-19 obese patients with type 1 and type 2 diabetes.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date April 1, 2021
Est. primary completion date March 15, 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years to 70 Years
Eligibility Inclusion Criteria: - Overweight patients with body mass index higher than 25 and obese patients with body mass index higher than 30 were selected to be included - Type one and type two diabetes mellitus patients were also included Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Egypt Faculty of medicine - sohag university Sohag

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measurement of matrix metalloproteinase-7 "MMP-7" serum level (pg/ml) as a biomarker of macrophage activation ELISA "Enzyme linked immunosorbent assay" technique. MMP-7 is measured after admission of patients to isolation hospital along 7 days interval for 21 days, 3 plasma samples are collected on the 7th day of admission, day 14 and day 21
Primary Measurement of matrix metalloproteinase-9 "MMP-9" serum level (pg/L) as a biomarker of macrophage activation ELISA "Enzyme linked immunosorbent assay" technique. MMP-9 is measured after admission of patients to isolation hospital along 7 days interval for 21 days, 3 plasma samples are collected on the 7th day of admission, day 14 and day 21
Primary Measurement of transforming growth factor B "TGF-B" serum level ( pg/ml) as a biomarker of macrophage activation ELISA "Enzyme linked immunosorbent assay" technique. TGF-B is measured after admission of patients to isolation hospital along 7 days interval for 21 days, 3 plasma samples are collected on the 7th day of admission, day 14 and day 21
Primary Measurement of platelet derived growth factor "PDGF" serum level (ng/ml) as a biomarker of macrophage activation ELISA "Enzyme linked immunosorbent assay" technique. PDGF is measured after admission of patients to isolation hospital along 7 days interval for 21 days, 3 plasma samples are collected on the 7th day of admission, day 14 and day 21
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