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NCT03276039 Clinical Trial

Serum Pentraxin-3 in Non-alcoholic Fatty Liver Disease With or Without Hepatitis C Virus

Non Alcoholic Fatty Liver Disease Clinical Trial

Official title:
Serum Pentraxin-3 in Non-alcoholic Fatty Liver Disease With or Without Hepatitis C Virus: A Comparative Egyptian Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03276039
Other study ID # 456
Secondary ID
Status Completed
Phase N/A
First received September 2, 2017
Last updated September 6, 2017
Start date April 15, 2014
Est. completion date July 30, 2016

Study information
Verified date September 2017
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study included 70 subjects divided into 3 groups. Group I included 25 patients with NAFLD. Group II included 25 patients with NAFLD and chronic HCV. Group III: included 20 controls. Abdominal ultrasound was done to patients and controls. Plasma pentraxin-3 (PTX3) was measured using ELISA. Comparison between three groups was done regarding plasma pentraxin-3. Higher levels of plasma PTX3 were detected in NAFLD patients irrespective of presence or absence of chronic HCV infection. Plasma PTX3 could be used as a non-invasive test for prediction of metabolic syndrome in the high-risk population with high sensitivity and moderate specificity.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date July 30, 2016
Est. primary completion date April 15, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients with NAFLD.

- Patients with NAFLD and chronic hepatitis C viral infection.

Exclusion Criteria:

- Current or past consumption of significant amount of alcohol more than 21 drinks and 14 drinks per week for men and women respectively.

- Patients receiving Drugs which cause fatty liver as amiodarone, diliazem, tamoxifen, steroids.

- Patients who take statins as it has lowering effect on plasma PTX3.

- Patients having any clinical evidence of hepatic decompensation, such as hepatic encephalopathy, ascites, variceal bleeding, elevated serum bilirubin level to more than two folds the upper limit of normal.

- Patients with heart failure.

- Patients with autoimmune rheumatic disease.

- Patients with chronic kidney diseases.

- Patients with sepsis.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• plasma pentraxin-3
Plasma pentraxin-3 was measured using ELISA

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Outcome
Type Measure Description Time frame Safety issue
Primary Plasma pentraxin-3 as a non invasive diagnostic marker in diagnosis of NAFLD in comparison to it's levels in patients with NAFLD and chronic hepatitis C viral infection Measurement of plasma pentraxin-3 in patients with NAFLD in comparison to it's levels in patients with hepatic steatosis on top of HCV and normal controls 1 year
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