Non Invasive Assessment of Liver Fibrosis in Fatty Liver Disease

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01874249

Enrollment

1200

Registered

2013-06-11

Start date

2012-07-31

Completion date

2016-08-31

Last updated

2018-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Alcoholic Fatty Liver Disease

Keywords

Hepatic fibrosis, Steatosis, Noninvasive markers.

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.

Interventions

OTHERElectronic detailed information

Electronic detailed information about non alcoholic fatty liver disease.

OTHERNAFLD Score

diagnosis of advanced fibrosis by NAFLD score, calculated according to Hepatology 2007;45(4):846-854

OTHERTransient elastography

Transient elastography values greater than 8 kPa

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 69 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026