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

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

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.

Study Overview

• Status: Completed
• Conditions: Non Alcoholic Fatty Liver Disease
• Intervention / Treatment: Diagnostic test: plasma pentraxin-3

• Study Type: Observational
• Enrollment (Actual): 70

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

50 adult Egyptian patients collected from Gastroenterology Unit, Internal Medicine, and Tropical Medicine Departments, were included. Additionally, 20 apparently healthy subjects were included as the control group. They were classified into three groups: Group I: included 25 patients with NAFLD diagnosed by radiological features and by exclusion of other causes of fatty liver.

Group II: included 25 patients with radiological features of NAFLD and laboratory evidence of chronic hepatitis C viral infection (positive PCR).

Group III: included 20 apparently healthy control subjects with negative medical history, normal physical examination, and normal laboratory and radiological examination.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
25 patients with non-alcoholic fatty liver disease	Diagnostic test: plasma pentraxin-3; Plasma pentraxin-3 was measured using ELISA
25 patients with NAFLD and chronic HCV	Diagnostic test: plasma pentraxin-3; Plasma pentraxin-3 was measured using ELISA
20 healthy controls	Diagnostic test: plasma pentraxin-3; Plasma pentraxin-3 was measured using ELISA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2014
• Primary Completion (Actual): April 15, 2016
• Study Completion (Actual): July 30, 2016

Study Registration Dates

• First Submitted: September 2, 2017
• First Submitted That Met QC Criteria: September 6, 2017
• First Posted (Actual): September 8, 2017

Study Record Updates

• Last Update Posted (Actual): September 8, 2017
• Last Update Submitted That Met QC Criteria: September 6, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Hepatitis C; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 456

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No