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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02394353

Enrollment

Registered

2015-03-20

Start date

2013-01-31

Completion date

2016-02-29

Last updated

2016-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatty Liver, Obesity

Keywords

bariatrics, transient elastography

Brief summary

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.

Interventions

DEVICETransient hepatic elastography

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

The eligibility criteria was: * morbid obesity patient grade II or grade III (BMI \> 35) in prepare to bariatric surgery.

Exclusion criteria

The

Design outcomes

Primary

Measure	Time frame	Description
Measure of fatty liver disease by transient hepatic elastography	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

Secondary

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

Other

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026