Non Invasive Assessment of Liver Fibrosis in Fatty Liver Disease

Non Alcoholic Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01874249
• Other study ID #: FAFLD
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Est. completion date: August 2016

Study information

• Verified date: August 2018
• Source: Fundación Clínica Médica Sur
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: August 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Fibrosis
• Liver Diseases
• Non Alcoholic Fatty Liver Disease
• Non-alcoholic Fatty Liver Disease

Intervention

Other:
• 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

Locations

Country	Name	City	State
Mexico	Medica Sur Clinic & Foundation	Mexico City	DF

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Clínica Médica Sur

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.