NCT02394353

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_1 obesity

Timeline
Completed

Started Jan 2013

Longer than P75 for phase_1 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 20, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

March 7, 2016

Status Verified

March 1, 2016

Enrollment Period

2.3 years

First QC Date

March 4, 2015

Last Update Submit

March 3, 2016

Conditions

ObesityFatty Liver

Keywords

bariatricstransient elastography

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Transversal study comparing comorbidities and transient hepatic elastography

    Participants will be submitted a correlation with comorbidities

Other Outcomes (1)

  • Prevalence of advanced fibrosis in assyntomatic obese patients

    Fibrosis will be assessed by transient hepatic elastography in the pre-operative period

Study Arms (2)

Sleeve Gastrectomy

ACTIVE COMPARATOR

Patients undergoing the sleeve gastrectomy surgery

Device: Transient hepatic elastography

Gastric Bypass

ACTIVE COMPARATOR

Patients undergoing the gastric bypass surgery

Device: Transient hepatic elastography

Interventions

Transient hepatic elastographyDEVICE
Gastric BypassSleeve Gastrectomy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fluminense Federal University

Niterói, Rio de Janeiro, Brazil

Location

Related Publications (2)

  • 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.

    PMID: 26803754DERIVED

  • 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.

    PMID: 25919069DERIVED

MeSH Terms

Conditions

ObesityFatty Liver

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsLiver DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fernando de Barros

Study Record Dates

First Submitted

March 4, 2015

First Posted

March 20, 2015

Study Start

January 1, 2013

Primary Completion

May 1, 2015

Study Completion

February 1, 2016

Last Updated

March 7, 2016

Record last verified: 2016-03

Locations

BR(1)