Non Invasive Assessment of Liver Fibrosis in Fatty Liver Disease

Fundación Clínica Médica Sur

Status: Completed

Conditions: Non Alcoholic Fatty Liver Disease

Treatments: Other: Electronic detailed information; Other: Transient elastography; Other: NAFLD Score

Study type: Interventional

Funder types: Other

Identifiers

NCT01874249

FAFLD

Details and patient eligibility

About

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.

Enrollment: 1,200 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,200 participants in 5 patient groups

Electronic detailed information

Experimental group

Description:

Standard of care for patients with diagnosis of fatty liver by ultrasound, plus electronic detailed information about non alcoholic fatty liver disease.

Treatment:

Other: Electronic detailed information

NAFLD Score

Experimental group

Description:

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.

Treatment:

Other: NAFLD Score

Other: Electronic detailed information

NAFLD Score plus Transient elastography

Experimental group

Description:

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.

Treatment:

Other: NAFLD Score

Other: Transient elastography

Other: Electronic detailed information

Transient elastography

Experimental group

Description:

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.

Treatment:

Other: Transient elastography

Other: Electronic detailed information

Standard of care

No Intervention group

Description:

Standard of care for patients with diagnosis of fatty liver by ultrasound.