Non Invasive Assessment of Liver Fibrosis in Fatty Liver Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01874249
• Date of registration: 05/06/2013
• Prospective Registration: No
• Primary sponsor: Fundación Clínica Médica Sur
• Public title: Non Invasive Assessment of Liver Fibrosis in Fatty Liver Disease
• Scientific title: Randomized Clinical Trial to Detect Advanced Fibrosis by Non-invasive Methods in Subjects With Non-alcoholic Fatty Liver Disease
• Date of first enrolment: July 2012
• Target sample size: 1200
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01874249
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Mexico

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 69 Years
Gender: All

Health Condition(s) or Problem(s) studied

Non Alcoholic Fatty Liver Disease

Intervention(s)

Other: NAFLD Score

Other: Transient elastography

Other: Electronic detailed information

Primary Outcome(s)

Advanced Fibrosis by any diagnostic modality [Time Frame: One year after the diagnosis of steatosis.]

Secondary Outcome(s)

Specialized care [Time Frame: One year after the diagnosis of steatosis.]

Secondary ID(s)

FAFLD

Source(s) of Monetary Support

Please refer to primary and secondary sponsors