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

NCT03276039 | Completed

• 1 other identifier: 456
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

25 patients with non-alcoholic fatty liver disease

Diagnostic Test: plasma pentraxin-3

25 patients with NAFLD and chronic HCV

Diagnostic Test: plasma pentraxin-3

20 healthy controls

Diagnostic Test: plasma pentraxin-3

Interventions

plasma pentraxin-3 DIAGNOSTIC_TEST

Plasma pentraxin-3 was measured using ELISA

20 healthy controls; 25 patients with NAFLD and chronic HCV; 25 patients with non-alcoholic fatty liver disease

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients with NAFLD.
• Patients with NAFLD and chronic hepatitis C viral infection.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 2, 2017
• First Posted: September 8, 2017
• Study Start: April 15, 2014
• Primary Completion: April 15, 2016
• Study Completion: July 30, 2016
• Last Updated: September 8, 2017

Record last verified: 2017-09