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Completed

NCT Number: NCT03276039

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

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.

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Key information

Conditions

Non Alcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

plasma pentraxin-3

Diagnostic Test

Plasma pentraxin-3 was measured using ELISA

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 8, 2017
Registry last updated
Sep 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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