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

NCT ID: NCT02394353

Last Updated: 2016-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2016-02-29

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.

Conditions

Obesity; Fatty Liver

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Sleeve Gastrectomy

Patients undergoing the sleeve gastrectomy surgery

Group Type: ACTIVE_COMPARATOR

Transient hepatic elastography

Intervention Type: DEVICE

Gastric Bypass

Patients undergoing the gastric bypass surgery

Group Type: ACTIVE_COMPARATOR

Transient hepatic elastography

Intervention Type: DEVICE

Interventions

Transient hepatic elastography

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

The eligibility criteria was:

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

Exclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Health, Brazil

OTHER_GOV

Sponsor Role: lead

Responsible Party

Fernando de Barros

Fernando de Barros

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fluminense Federal University

Niterói, Rio de Janeiro, Brazil

Countries

Brazil

References

de Barros F, Setubal S, Martinho JM, Leite NC, Guarana T, Monteiro ABS, Villela-Nogueira CA. The Correlation Between Obesity-Related Diseases and Non-alcoholic Fatty Liver Disease in Women in the Pre-operative Evaluation for Bariatric Surgery Assessed by Transient Hepatic Elastography. Obes Surg. 2016 Sep;26(9):2089-2097. doi: 10.1007/s11695-016-2054-y.

Reference Type: DERIVED

PMID: 26803754 (View on PubMed)

de Barros F, Setubal S, Martinho JM, Monteiro AB. Early Endocrine and Metabolic Changes After Bariatric Surgery in Grade III Morbidly Obese Patients: A Randomized Clinical Trial Comparing Sleeve Gastrectomy and Gastric Bypass. Metab Syndr Relat Disord. 2015 Aug;13(6):264-71. doi: 10.1089/met.2014.0152. Epub 2015 Apr 28.

Reference Type: DERIVED

PMID: 25919069 (View on PubMed)

Other Identifiers

Interventions

Identifier Type: -

Identifier Source: org_study_id