Non Invasive Assessment of Liver Fibrosis in Fatty Liver Disease

Sponsor

Fundación Clínica Médica Sur (Other)

Overall Status

Completed

CT.gov ID

NCT01874249

Collaborator

(none)

1,200

Enrollment

Location

Arms

Duration (Months)

24.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non Alcoholic Fatty Liver Disease	Other: Electronic detailed information Other: NAFLD Score Other: Transient elastography	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

1200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: Electronic detailed information Electronic detailed information about non alcoholic fatty liver disease.
Experimental: 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.	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
Experimental: NAFLD Score plus 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.	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
Experimental: 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.	Other: Electronic detailed information Electronic detailed information about non alcoholic fatty liver disease. Other: Transient elastography Transient elastography values greater than 8 kPa
No Intervention: Standard of care Standard of care for patients with diagnosis of fatty liver by ultrasound.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 69 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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