Clinical trial NCT02394353: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Fatty Liver
Keywords: bariatrics
transient elastography
Lead sponsor: Ministry of Health, Brazil
Sponsor class: OTHER_GOV
First posted: 2015-03-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Measure of fatty liver disease by transient hepatic elastography
timeFrame: Participants will be followed an average of 3 months
Secondary outcomes:
measure: Transversal study comparing comorbidities and transient hepatic elastography
timeFrame: Participants will be submitted a correlation with comorbidities
Other outcomes:
measure: Prevalence of advanced fibrosis in assyntomatic obese patients
timeFrame: Fibrosis will be assessed by transient hepatic elastography in the pre-operative period
Locations:
city: Niteroi
country: Brazil
facility: Fluminense Federal University
state: Rio de Janeiro
Study officials:
References:
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.
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.