Skip to main content
OpenTrials
Completed

NCT Number: NCT02394353

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Body Weight Digestive System Diseases Fatty Liver Liver Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fluminense Federal University

Niterói, Rio de Janeiro, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Transient hepatic elastography

Device

Primary outcomes

  1. Measure of fatty liver disease by transient hepatic elastography

    Time frame: Participants will be followed an average of 3 months

    Tha aim is to compare the evolution of the fatty liver disease between the sleeve gastrectomy and gastric bypass

Secondary outcomes

  1. Transversal study comparing comorbidities and transient hepatic elastography

    Time frame: Participants will be submitted a correlation with comorbidities

    Tha aim is to find some relationship

Other outcomes

  1. Prevalence of advanced fibrosis in assyntomatic obese patients

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

    Tha aim is identified patients with advanced disease

Sponsors and collaborators

Lead sponsor

Ministry of Health, Brazil

Other Gov

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Mar 20, 2015
Registry last updated
Mar 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.