Non Invasive Assessment of Liver Fibrosis in Fatty Liver Disease

Fundación Clínica Médica Sur1,200 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

1,200

Conditions

Non Alcoholic Fatty Liver Disease

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 69 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Advanced Fibrosis by any diagnostic modality

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.

Time frame: One year after the diagnosis of steatosis.

Secondary Outcomes

Specialized care

Through telephone follow-up, investigate if the patient attends to gastroenterologist or endocrinologist for examination, diagnostic confirmation or any treatment.