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

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT03276039
Collaborator
(none)
70
Enrollment
27.5
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: plasma pentraxin-3

Study Design

Study Type:
Observational
Actual Enrollment :
70 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Serum Pentraxin-3 in Non-alcoholic Fatty Liver Disease With or Without Hepatitis C Virus: A Comparative Egyptian Study
Actual Study Start Date :
Apr 15, 2014
Actual Primary Completion Date :
Apr 15, 2016
Actual Study Completion Date :
Jul 30, 2016

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shereen Abou Bakr Saleh, Assistant Professor, Ain Shams University
ClinicalTrials.gov Identifier:
NCT03276039
Other Study ID Numbers:
  • 456
First Posted:
Sep 8, 2017
Last Update Posted:
Sep 8, 2017
Last Verified:
Sep 1, 2017
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hepatitis C
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of Sep 8, 2017