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Non Invasive Assessment of Liver Fibrosis in Fatty Liver Disease

Primary Purpose

Non Alcoholic Fatty Liver Disease

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Electronic detailed information
NAFLD Score
Transient elastography
Sponsored by
Fundación Clínica Médica Sur
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Non Alcoholic Fatty Liver Disease focused on measuring Hepatic fibrosis, Steatosis, Noninvasive markers.

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Medica Sur Clinic & Foundation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

No Intervention

Arm Label

Electronic detailed information

NAFLD Score

NAFLD Score plus Transient elastography

Transient elastography

Standard of care

Arm Description

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

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.

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.

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Specialized care
Through telephone follow-up, investigate if the patient attends to gastroenterologist or endocrinologist for examination, diagnostic confirmation or any treatment.

Full Information

First Posted
June 5, 2013
Last Updated
August 8, 2018
Sponsor
Fundación Clínica Médica Sur
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1. Study Identification

Unique Protocol Identification Number
NCT01874249
Brief Title
Non Invasive Assessment of Liver Fibrosis in Fatty Liver Disease
Official Title
Randomized Clinical Trial to Detect Advanced Fibrosis by Non-invasive Methods in Subjects With Non-alcoholic Fatty Liver Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundación Clínica Médica Sur

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Alcoholic Fatty Liver Disease
Keywords
Hepatic fibrosis, Steatosis, Noninvasive markers.

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electronic detailed information
Arm Type
Experimental
Arm Description
Standard of care for patients with diagnosis of fatty liver by ultrasound, plus electronic detailed information about non alcoholic fatty liver disease.
Arm Title
NAFLD Score
Arm Type
Experimental
Arm Description
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.
Arm Title
NAFLD Score plus Transient elastography
Arm Type
Experimental
Arm Description
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.
Arm Title
Transient elastography
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Standard of care for patients with diagnosis of fatty liver by ultrasound.
Intervention Type
Other
Intervention Name(s)
Electronic detailed information
Intervention Description
Electronic detailed information about non alcoholic fatty liver disease.
Intervention Type
Other
Intervention Name(s)
NAFLD Score
Intervention Description
diagnosis of advanced fibrosis by NAFLD score, calculated according to Hepatology 2007;45(4):846-854
Intervention Type
Other
Intervention Name(s)
Transient elastography
Intervention Description
Transient elastography values greater than 8 kPa
Primary Outcome Measure Information:
Title
Advanced Fibrosis by any diagnostic modality
Description
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.
Time Frame
One year after the diagnosis of steatosis.
Secondary Outcome Measure Information:
Title
Specialized care
Description
Through telephone follow-up, investigate if the patient attends to gastroenterologist or endocrinologist for examination, diagnostic confirmation or any treatment.
Time Frame
One year after the diagnosis of steatosis.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Medica Sur Clinic & Foundation
City
Mexico City
State/Province
DF
ZIP/Postal Code
14050
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
35585153
Citation
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.
Results Reference
derived

Learn more about this trial

Non Invasive Assessment of Liver Fibrosis in Fatty Liver Disease

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