Non Invasive Assessment of Liver Fibrosis in Fatty Liver Disease

Study Overview
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Brief Summary
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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.

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

Conditions
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Non Alcoholic Fatty Liver Disease

Intervention / Treatment
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* Other: Electronic detailed information
* Other: NAFLD Score
* Other: Transient elastography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electronic detailed information<br>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<br>* Electronic detailed information about non alcoholic fatty liver disease.<br>|
| Experimental: NAFLD Score<br>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<br>* Electronic detailed information about non alcoholic fatty liver disease.<br>Other: NAFLD Score<br>* diagnosis of advanced fibrosis by NAFLD score, calculated according to Hepatology 2007;45(4):846-854<br>|
| Experimental: NAFLD Score plus Transient elastography<br>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<br>* Electronic detailed information about non alcoholic fatty liver disease.<br>Other: NAFLD Score<br>* diagnosis of advanced fibrosis by NAFLD score, calculated according to Hepatology 2007;45(4):846-854<br>Other: Transient elastography<br>* Transient elastography values greater than 8 kPa<br>|
| Experimental: Transient elastography<br>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<br>* Electronic detailed information about non alcoholic fatty liver disease.<br>Other: Transient elastography<br>* Transient elastography values greater than 8 kPa<br>|
| No Intervention: Standard of care<br>Standard of care for patients with diagnosis of fatty liver by ultrasound. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | One year after the diagnosis of steatosis. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specialized care | Through telephone follow-up, investigate if the patient attends to gastroenterologist or endocrinologist for examination, diagnostic confirmation or any treatment. | One year after the diagnosis of steatosis. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatic fibrosis, Steatosis, Noninvasive markers.