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Non Invasive Assessment of Liver Fibrosis in Fatty Liver Disease

NCT01874249 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2018-08-09

No results posted yet for this study

Summary

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.

Conditions

  • Non Alcoholic Fatty Liver Disease

Interventions

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

Sponsors & Collaborators

  • Fundación Clínica Médica Sur

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2015-08-31
Completion
2016-08-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01874249 on ClinicalTrials.gov