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

Obesity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02394353
• Other study ID #: Interventions
• Status: Completed
• Phase: Phase 1
• First received: March 4, 2015
• Last updated: March 3, 2016
• Start date: January 2013
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: Ministry of Health, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Obesity

Intervention

Device:
• Transient hepatic elastography

Locations

Country	Name	City	State
Brazil	Fluminense Federal University	Niteroi	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Health, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Prevalence of advanced fibrosis in assyntomatic obese patients	Tha aim is identified patients with advanced disease	Fibrosis will be assessed by transient hepatic elastography in the pre-operative period	Yes
Primary	Measure of fatty liver disease by transient hepatic elastography	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	Yes
Secondary	Transversal study comparing comorbidities and transient hepatic elastography	Tha aim is to find some relationship	Participants will be submitted a correlation with comorbidities	Yes