Non Invasive Assessment of Liver Fibrosis in Fatty Liver Disease

August 8, 2018 updated by: Norberto Carlos Chavez Taia, Fundación Clínica Médica Sur

Randomized Clinical Trial to Detect Advanced Fibrosis by Non-invasive Methods in Subjects With Non-alcoholic Fatty Liver Disease

The purpose of this randomized clinical trial is to evaluate the utility of noninvasive markers for the detection of advanced fibrosis in patients newly diagnosed with Non-alcoholic Fatty Liver Disease (NAFLD) by ultrasound.

The primary objective is to determine the effectiveness of noninvasive markers for detect of advanced fibrosis in patients with diagnosis of fatty liver disease.

The secondary objectives are:

  • To determine the increase in health care with the specialist (gastroenterologist or endocrinologist).
  • To determine which noninvasive evaluation strategy favors any treatment of fatty liver disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • DF
      • Mexico City, DF, Mexico, 14050
        • Medica Sur Clinic & Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with BMI ≥ 27 Kg/m2 and any stage of non alcoholic fatty liver, diagnosed by ultrasound.

Exclusion Criteria:

  • Patients with other liver disease.
  • Patients under treatment with tamoxifen, methotrexate, amiodarone, diltiazem or other drugs able to induce fatty liver.
  • Patients with alcohol consumption greater than 140 gr. per week
  • Patients who have received blood transfusion before 1990

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electronic detailed information
Standard of care for patients with diagnosis of fatty liver by ultrasound, plus electronic detailed information about non alcoholic fatty liver disease.
Other: Electronic detailed information
Electronic detailed information about non alcoholic fatty liver disease.
Experimental: NAFLD Score
Standard of care for patients with diagnosis of fatty liver by ultrasound, plus electronic detailed information about non alcoholic fatty liver disease, plus diagnosis of advanced fibrosis by NAFLD score.
Other: Electronic detailed information
Electronic detailed information about non alcoholic fatty liver disease.
Other: NAFLD Score
diagnosis of advanced fibrosis by NAFLD score, calculated according to Hepatology 2007;45(4):846-854
Experimental: NAFLD Score plus Transient elastography
Standard of care for patients with diagnosis of fatty liver by ultrasound, plus electronic detailed information about non alcoholic fatty liver disease, plus diagnosis of advanced fibrosis by NAFLD score and transient elastography.
Other: Electronic detailed information
Electronic detailed information about non alcoholic fatty liver disease.
Other: NAFLD Score
diagnosis of advanced fibrosis by NAFLD score, calculated according to Hepatology 2007;45(4):846-854
Other: Transient elastography
Transient elastography values greater than 8 kPa
Experimental: Transient elastography
Standard of care for patients with diagnosis of fatty liver by ultrasound, plus electronic detailed information about non alcoholic fatty liver disease, plus diagnosis of advanced fibrosis by transient elastography.
Other: Electronic detailed information
Electronic detailed information about non alcoholic fatty liver disease.
Other: Transient elastography
Transient elastography values greater than 8 kPa
No Intervention: Standard of care
Standard of care for patients with diagnosis of fatty liver by ultrasound.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Advanced Fibrosis by any diagnostic modality
Time Frame: One year after the diagnosis of steatosis.
Evidence of advanced fibrosis, diagnosed by transient elastography (greater than 8 kPa), NAFLD Score above 0.675, liver biopsy or any other non-invasive marker of liver fibrosis.
One year after the diagnosis of steatosis.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specialized care
Time Frame: One year after the diagnosis of steatosis.
Through telephone follow-up, investigate if the patient attends to gastroenterologist or endocrinologist for examination, diagnostic confirmation or any treatment.
One year after the diagnosis of steatosis.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Clínica Médica Sur

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

June 5, 2013

First Submitted That Met QC Criteria

June 10, 2013

First Posted (Estimate)

June 11, 2013

Study Record Updates

Last Update Posted (Actual)

August 9, 2018

Last Update Submitted That Met QC Criteria

August 8, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAFLD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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