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

Completed

• Conditions: Non Alcoholic Fatty Liver Disease
• Interventions: Diagnostic Test: plasma pentraxin-3

• Registration Number: NCT03276039
• Lead Sponsor: Ain Shams University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-15
• Primary Completion: 2016-04-15
• Study Completion: 2016-07-30
• Status Verified: 2017-09
• Study First Submitted: 2017-09-02
• Study First Submitted QC: 2017-09-06
• Last Update Submitted: 2017-09-06
• Study First Posted: 2017-09-08
• Last Update Posted: 2017-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
25 patients with NAFLD and chronic HCV	plasma pentraxin-3	-
25 patients with non-alcoholic fatty liver disease	plasma pentraxin-3	-
20 healthy controls	plasma pentraxin-3	-

Primary Outcome Measures

Name	Time	Method
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	1 year	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