Early Detection of Advanced Fatty Liver Disease

NCT03608748 | Completed

• 1 other identifier: 007-18-EMC
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Non-alcoholic fatty liver disease is the most common cause of chronic liver disease in the western world, affecting one in every three subjects. The investigators hypothesize that a patient population without known liver disease has a certain percentage of patients with liver fibrosis who are undiagnosed and not monitored.

Conditions

Non-alcoholic Fatty Liver Disease; Liver Fibrosis

Keywords

Nafld Score; Elastography

Outcome Measures

Primary Outcomes (1)

• Non-Alcoholic Fatty Liver Disease Score

  Non-alcoholic fatty liver disease Score (Nafld Score) is a non-invasive scoring system based on several laboratory tests that helps to estimate the amount of scarring in the liver. The score is made up of six parameters: age, BMI(body mass index), aspartate aminotransferase(AST) / alanine transaminase(ALT), platelet count, impaired fasting glucose(IFG), albumin. The Nafld Score formula is: -1.675 + 0.037 × age (years) + 0.094 × BMI (kg/m\^2) + 1.13 × IFG/diabetes (yes = 1, no = 0) + 0.99 × AST/ALT ratio - 0.013 × platelets (×10\^9/l) - 0.66 × albumin (g/dl). 2 cutoff points were selected to identify the presence (\> 0.675) and absence (\< -1.455) of significant fibrosis. \< -1.455: predictor of absence of significant fibrosis (F0-F2 fibrosis), negative predictive value 93% . between -1.455 and 0.675: indeterminate score. \>0.675: predictor of presence of significant fibrosis (F3-F4 fibrosis), positive predictive value of 90%. The score will be calculated for all the participants.

  Up to five minutes

Secondary Outcomes (1)

• Elastography Test

  Up to two hours

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

All patients aged 45-60 years old without known liver disease who belong to an initial clinic which was chosen arbitrarily.

You may qualify if:

• Subjects aged 45-60 who belong to an initial clinic which was chosen arbitrarily.
• Subjects without known liver disease.
• Subjects agree to sign a consent form. -

You may not qualify if:

• History of right-sided heart failure
• History of liver disease including positive infectious serology for hepatitis B or C
• Pregnant women
• People incapable of judgment -

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

Haemek medical center

Afula, 1834111, Israel

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rawi Hazzan, Dr

  haemek medical center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Liver Unit

Study Record Dates

• First Submitted: July 8, 2018
• First Posted: August 1, 2018
• Study Start: November 1, 2018
• Primary Completion: December 31, 2022
• Study Completion: March 1, 2023
• Last Updated: February 29, 2024

Record last verified: 2024-02

Locations

IL (1)