Non Invasive Assessment of Liver Fibrosis in Fatty Liver Disease

NCT01874249 | Completed DMC

• 1 other identifier: FAFLD
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Alcoholic Fatty Liver Disease

Keywords

Hepatic fibrosis; Steatosis; Noninvasive markers.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Specialized care

  One year after the diagnosis of steatosis.

Study Arms (5)

Electronic detailed information

EXPERIMENTAL

Standard of care for patients with diagnosis of fatty liver by ultrasound, plus electronic detailed information about non alcoholic fatty liver disease.

Other: Electronic detailed information

NAFLD Score

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.

Other: Electronic detailed information; Other: NAFLD Score

NAFLD Score plus Transient elastography

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.

Other: Electronic detailed information; Other: NAFLD Score; Other: Transient elastography

Transient elastography

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.

Other: Electronic detailed information; Other: Transient elastography

Standard of care

NO INTERVENTION

Standard of care for patients with diagnosis of fatty liver by ultrasound.

Interventions

Electronic detailed information OTHER

Electronic detailed information about non alcoholic fatty liver disease.

Electronic detailed information; NAFLD Score; NAFLD Score plus Transient elastography; Transient elastography

NAFLD Score OTHER

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

NAFLD Score; NAFLD Score plus Transient elastography

Transient elastography OTHER

Transient elastography values greater than 8 kPa

NAFLD Score plus Transient elastography; Transient elastography

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with BMI ≥ 27 Kg/m2 and any stage of non alcoholic fatty liver, diagnosed by ultrasound.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación Clínica Médica Sur: lead

Study Sites (1)

Medica Sur Clinic & Foundation

Mexico City, Mexico City, 14050, Mexico

Location

Related Publications (1)

• Chavez-Tapia NC, Barrientos-Gutierrez T, Torres-Ibarra L, Sanchez-Jimenez B, Juarez-Hernandez E, Ramos-Ostos M, Alva-Lopez LF, Uribe M. Incremental levels of diagnostic information incentivize health-seeking in non-alcoholic fatty liver: a randomized clinical trial. Sci Rep. 2022 May 18;12(1):8272. doi: 10.1038/s41598-022-12295-1.

  PMID: 35585153 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Cirrhosis; Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Norberto Carlos Chavez-Tapia

Study Record Dates

• First Submitted: June 5, 2013
• First Posted: June 11, 2013
• Study Start: July 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2016
• Last Updated: August 9, 2018

Record last verified: 2018-08

Locations

ME (1)