Impact of Bariatric Surgery on the Evolution of Nonalcoholic Fatty Liver Disease: a Comparative Clinical Trial Between Sleeve Gastrectomy and Gastric Bypass

March 3, 2016 updated by: Fernando de Barros, Ministry of Health, Brazil
Aim: To compare prospectively two bariatric surgery techniques: sleeve gastrectomy (SG) vs gastric bypass (GB) in the evolution of nonalcoholic fatty liver disease (NAFLD) measured by the transient elastography in the first year. Methods: This is a randomized clinical trial with morbidly obese patients, between 18-60 years old from a Federal Hospital, Ministry of Health, Brazil. Patients were divided into 2 groups: group 1 - SG (n = 30) and group 2 - GB (n = 30). The randomization was made by lots. In the GB the investigators created 30 ml pouch, with a pancreatic and an alimentary limb of 1 meter, and a calibrated gastroenterostomy (1.5 cm diameter). In SG the investigators calibrated the gastric tube with a bougie number 32 (70 ml). The variables were compared one week before surgery and in the postoperative time (1, 3, 6 and 12 months). The variables were: patient anthropometry, laboratory tests and the transient liver elastography.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio de Janeiro
      • Niteroi, Rio de Janeiro, Brazil
        • Fluminense Federal University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

The eligibility criteria was:

  • morbid obesity patient grade II or grade III (BMI > 35) in prepare to bariatric surgery.

Exclusion Criteria:

The exclusion criteria were:

  • age under 18 years or greater than 65 years old,
  • chronic diseases (heart failure, chronic liver disease), and
  • alcohol abuse (abuse was considered in those who consume more than 14 drinks per week).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sleeve Gastrectomy
Patients undergoing the sleeve gastrectomy surgery
Device: Transient hepatic elastography
Active Comparator: Gastric Bypass
Patients undergoing the gastric bypass surgery
Device: Transient hepatic elastography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of fatty liver disease by transient hepatic elastography
Time Frame: Participants will be followed an average of 3 months
Tha aim is to compare the evolution of the fatty liver disease between the sleeve gastrectomy and gastric bypass
Participants will be followed an average of 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transversal study comparing comorbidities and transient hepatic elastography
Time Frame: Participants will be submitted a correlation with comorbidities
Tha aim is to find some relationship
Participants will be submitted a correlation with comorbidities

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of advanced fibrosis in assyntomatic obese patients
Time Frame: Fibrosis will be assessed by transient hepatic elastography in the pre-operative period
Tha aim is identified patients with advanced disease
Fibrosis will be assessed by transient hepatic elastography in the pre-operative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ministry of Health, Brazil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

March 4, 2015

First Submitted That Met QC Criteria

March 16, 2015

First Posted (Estimate)

March 20, 2015

Study Record Updates

Last Update Posted (Estimate)

March 7, 2016

Last Update Submitted That Met QC Criteria

March 3, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Interventions

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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