NCT01874249

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,200 (actual)
• Sponsor: Fundación Clínica Médica Sur · Academic / Other
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Accepted

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.

Conditions

• Non Alcoholic Fatty Liver Disease

Interventions

Type	Name	Description
OTHER	Electronic detailed information	Electronic detailed information about non alcoholic fatty liver disease.
OTHER	NAFLD Score	diagnosis of advanced fibrosis by NAFLD score, calculated according to Hepatology 2007;45(4):846-854
OTHER	Transient elastography	Transient elastography values greater than 8 kPa

Timeline

• Start date: 2012-07-01
• Primary completion: 2015-08-01
• Completion: 2016-08-01
• First posted: 2013-06-11
• Last updated: 2018-08-09

Locations

1 site across 1 country: Mexico