Skip to main content
OpenTrials
Completed

NCT Number: NCT01874249

Non Invasive Assessment of Liver Fibrosis in 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Non Alcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Fibrosis Liver Cirrhosis Liver Diseases Non-alcoholic Fatty Liver Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medica Sur Clinic & Foundation

Mexico City, 14050, Mexico

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Electronic detailed information

Other

Electronic detailed information about non alcoholic fatty liver disease.

NAFLD Score

Other

diagnosis of advanced fibrosis by NAFLD score, calculated according to Hepatology 2007;45(4):846-854

Transient elastography

Other

Transient elastography values greater than 8 kPa

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Fundación Clínica Médica Sur

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Jun 11, 2013
Registry last updated
Aug 9, 2018

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.