Non Invasive Assessment of Liver Fibrosis in Fatty Liver Disease
NCT ID: NCT01874249
Last Updated: 2018-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1200 participants
INTERVENTIONAL
2012-07-31
2016-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Electronic detailed information
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.
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.
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
NAFLD Score plus 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 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
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.
Electronic detailed information
Electronic detailed information about non alcoholic fatty liver disease.
Transient elastography
Transient elastography values greater than 8 kPa
Standard of care
Standard of care for patients with diagnosis of fatty liver by ultrasound.
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
69 Years
ALL
Yes
Sponsors
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Fundación Clínica Médica Sur
OTHER
Responsible Party
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Norberto Carlos Chavez Taia
Norberto Carlos Chavez-Tapia
Locations
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Medica Sur Clinic & Foundation
Mexico City, Mexico City, Mexico
Countries
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References
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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.
Other Identifiers
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FAFLD
Identifier Type: -
Identifier Source: org_study_id
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