Overview

This trial is active, not recruiting.

Condition non alcoholic fatty liver disease
Treatments electronic detailed information, nafld score, transient elastography
Sponsor Fundación Clínica Médica Sur
Start date July 2012
End date August 2015
Trial size 594 participants
Trial identifier NCT01874249, FAFLD

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose diagnostic
Arm
(Experimental)
Standard of care for patients with diagnosis of fatty liver by ultrasound, plus electronic detailed information about non alcoholic fatty liver disease.
electronic detailed information
Electronic detailed information about non alcoholic fatty liver disease.
(Experimental)
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.
electronic detailed information
Electronic detailed information about non alcoholic fatty liver disease.
nafld score
diagnosis of advanced fibrosis by NAFLD score, calculated according to Hepatology 2007;45(4):846-854
(Experimental)
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.
electronic detailed information
Electronic detailed information about non alcoholic fatty liver disease.
nafld score
diagnosis of advanced fibrosis by NAFLD score, calculated according to Hepatology 2007;45(4):846-854
transient elastography
Transient elastography values greater than 8 kPa
(Experimental)
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.
electronic detailed information
Electronic detailed information about non alcoholic fatty liver disease.
transient elastography
Transient elastography values greater than 8 kPa
(No Intervention)
Standard of care for patients with diagnosis of fatty liver by ultrasound.

Primary Outcomes

Measure
Advanced Fibrosis by any diagnostic modality
time frame: One year after the diagnosis of steatosis.

Secondary Outcomes

Measure
Specialized care
time frame: One year after the diagnosis of steatosis.

Eligibility Criteria

Male or female participants from 18 years up to 69 years old.

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

Additional Information

Official title Randomized Clinical Trial to Detect Advanced Fibrosis by Non-invasive Methods in Subjects With Non-alcoholic Fatty Liver Disease
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Fundación Clínica Médica Sur.