Non Invasive Assessment of Liver Fibrosis in Fatty Liver Disease

NCT ID: NCT01874249

Last Updated: 2018-08-09

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2016-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Non Alcoholic Fatty Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

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.

Group Type EXPERIMENTAL

Electronic detailed information

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Electronic detailed information

Intervention Type OTHER

Electronic detailed information about non alcoholic fatty liver disease.

NAFLD Score

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Electronic detailed information

Intervention Type OTHER

Electronic detailed information about non alcoholic fatty liver disease.

NAFLD Score

Intervention Type OTHER

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

Transient elastography

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Electronic detailed information

Intervention Type OTHER

Electronic detailed information about non alcoholic fatty liver disease.

Transient elastography

Intervention Type OTHER

Transient elastography values greater than 8 kPa

Standard of care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Electronic detailed information

Electronic detailed information about non alcoholic fatty liver disease.

Intervention Type OTHER

NAFLD Score

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

Intervention Type OTHER

Transient elastography

Transient elastography values greater than 8 kPa

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fundación Clínica Médica Sur

OTHER

Sponsor Role lead

Responsible Party

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Norberto Carlos Chavez Taia

Norberto Carlos Chavez-Tapia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medica Sur Clinic & Foundation

Mexico City, Mexico City, Mexico

Site Status

Countries

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Mexico

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.

Reference Type DERIVED
PMID: 35585153 (View on PubMed)

Other Identifiers

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FAFLD

Identifier Type: -

Identifier Source: org_study_id

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