Back to resultsImpact of Bariatric Surgery on the Evolution of Nonalcoholic Fatty Liver Disease: a Comparative Clinical Trial Between Sleeve Gastrectomy and Gastric Bypass
Primary Purpose
Obesity, Fatty Liver
Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Transient hepatic elastography
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring bariatrics, transient elastography
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:
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).
Sites / Locations
- Fluminense Federal University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Sleeve Gastrectomy
Gastric Bypass
Arm Description
Patients undergoing the sleeve gastrectomy surgery
Patients undergoing the gastric bypass surgery
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Transversal study comparing comorbidities and transient hepatic elastography
Tha aim is to find some relationship
Full Information
NCT ID
NCT02394353
First Posted
March 4, 2015
Last Updated
March 3, 2016
Sponsor
Ministry of Health, Brazil
1. Study Identification
Unique Protocol Identification Number
NCT02394353
Brief Title
Impact of Bariatric Surgery on the Evolution of Nonalcoholic Fatty Liver Disease: a Comparative Clinical Trial Between Sleeve Gastrectomy and Gastric Bypass
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Health, Brazil
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Fatty Liver
Keywords
bariatrics, transient elastography
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sleeve Gastrectomy
Arm Type
Active Comparator
Arm Description
Patients undergoing the sleeve gastrectomy surgery
Arm Title
Gastric Bypass
Arm Type
Active Comparator
Arm Description
Patients undergoing the gastric bypass surgery
Intervention Type
Device
Intervention Name(s)
Transient hepatic elastography
Primary Outcome Measure Information:
Title
Measure of fatty liver disease by transient hepatic elastography
Description
Tha aim is to compare the evolution of the fatty liver disease between the sleeve gastrectomy and gastric bypass
Time Frame
Participants will be followed an average of 3 months
Secondary Outcome Measure Information:
Title
Transversal study comparing comorbidities and transient hepatic elastography
Description
Tha aim is to find some relationship
Time Frame
Participants will be submitted a correlation with comorbidities
Other Pre-specified Outcome Measures:
Title
Prevalence of advanced fibrosis in assyntomatic obese patients
Description
Tha aim is identified patients with advanced disease
Time Frame
Fibrosis will be assessed by transient hepatic elastography in the pre-operative period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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:
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).
Facility Information:
Facility Name
Fluminense Federal University
City
Niteroi
State/Province
Rio de Janeiro
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
26803754
Citation
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.
Results Reference
derived
PubMed Identifier
25919069
Citation
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.
Results Reference
derived
Learn more about this trial
Impact of Bariatric Surgery on the Evolution of Nonalcoholic Fatty Liver Disease: a Comparative Clinical Trial Between Sleeve Gastrectomy and Gastric Bypass
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