Non Invasive Assessment of Liver Fibrosis in Fatty Liver Disease

Not Applicable

Completed

• Conditions: Non Alcoholic Fatty Liver Disease
• Interventions: Other: Electronic detailed information; Other: Transient elastography; Other: NAFLD Score

• Registration Number: NCT01874249
• Lead Sponsor: Fundación Clínica Médica Sur

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2013-06-05
• Study First Submitted QC: 2013-06-10
• Study First Posted: 2013-06-11
• Primary Completion: 2015-08
• Study Completion: 2016-08
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-08
• Last Update Posted: 2018-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NAFLD Score plus Transient elastography	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, plus diagnosis of advanced fibrosis by NAFLD score and transient elastography.
Transient elastography	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.
NAFLD Score plus Transient elastography	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 and transient elastography.
Electronic detailed information	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.
NAFLD Score	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.
Transient elastography	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, plus diagnosis of advanced fibrosis by transient elastography.
NAFLD Score	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, plus diagnosis of advanced fibrosis by NAFLD score.
NAFLD Score plus Transient elastography	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.

Primary Outcome Measures

Name	Time	Method
Advanced Fibrosis by any diagnostic modality	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 Outcome Measures

Name	Time	Method
Specialized care	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.

Trial Locations

Locations (1)

Medica Sur Clinic & Foundation; 🇲🇽 Mexico City, DF, Mexico