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Completed

NCT Number: NCT00793143

Laparoscopic Gastric Bypass Versus Sleeve Gastrectomy to Treat Morbid Obesity

Bariatric surgery in the treatment of morbid obesity is associated with long-term weight-loss and decreased overall mortality. Long-term results have been reported for laparoscopic gastric bypass procedures but the long-term results of laparoscopic sleeve gastrectomy are yet unavailable. As sleeve gastrectomy is a rapid and less traumatic procedure with good short-term results of weight loss and resolution of comorbidities, the investigators initiated a prospective randomized two-center study comparing laparoscopic sleeve gastrectomy (LSG)with laparoscopic gastric bypass (LGB) in the treatment of morbid obesity. Study hypothesis: As sleeve gastrectomy is less traumatic, easier and faster to perform compared with gastric bypass,LSG could become the procedure of choice to treat morbid obesity if the long-term results of weight loss and resolution of comorbidities are comparable with laparoscopic gastric bypass.

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Key information

Conditions

Morbid Obesity Body Weight Body Weight Changes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Helsinki University Hospital, Helsinki, Finland

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About this study

In addition to comparing the outcomes between sleeve gastrectomy and gastric bypass, the study project includes a PET trial conducted in Turku. The objectives of this PET study are to measure effect of obesity on food-stimuli mediated brain activation response and on hormones affecting both feeding and energy balance. In the second part the same variables are studied after bariatric surgery: either laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass. In addition the effect of weight loss due to bariatric surgery on glucose uptake and free fatty acid metabolism is measured. The objective is also to study whether less invasive sleeve gastrectomy is as beneficial in terms of weight loss and co-morbid diseases as more invasive Roux-en-Y gastric bypass and to compare the risk factors between these two surgical procedures. Regional glucose uptake and free fatty acid uptake in myocardium, skeletal muscle, subcutaneous fat, visceral fat, pancreas, liver and brain are studied with PET at baseline before bariatric surgery and post-operatively on the 3rd month. Changes in body fat distribution, in ectopic fat and fat content of key organs are investigated with magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS). Brain reward system response to food stimuli is assessed using functional MRI (fMRI) and white and grey matter volumes using diffusion tensor imaging (DTI).

The study consists of 80 morbidly obese adults, BMI ≥ 40 kg/m2 or if there is additional risk factor BMI ≥ 35 kg/m2. From these subjects, 40 are further studied with positron emission tomography (PET) and magnetic resonance imaging (MRI). In addition functional MRI (fMRI) will be performed for 40 subjects. For fMRI, a control group is recruited consisting of 20 lean and healthy subjects. Subjects are physically examined and anthropometric data are measured along with blood sampling.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • BMI > 40 or BMI > 35 with a comorbidity associated with obesity
  • Age 18 - 60 years
  • Failed prior effective and controlled conservative treatments of morbid obesity

Exclusion criteria

  • BMI > 60
  • Difficult psychiatric conditions or lack of co-operation
  • Difficult eating disorder (binge eating, bulimia etc.)
  • Alcohol abuse
  • Gastric ulcer

Treatment and study plan

Primary outcomes

  1. Excessive weight loss

    Time frame: 3,6,12,18 months, 2,3,5,7,10,15 years

Secondary outcomes

  1. Resolution of comorbidities

    Time frame: 3,6,12,18 months, 2,3,5,7,10,15 years

  2. Mortality

    Time frame: 0 - 15 years

  3. Morbidity

    Time frame: 0 - 15 years

  4. QOL (15D and BAROS)

    Time frame: 3,6,12,18 months, 2,3,5,7,10,15 years

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Collaborators

  • Helsinki University Central Hospital
  • Vaasa Central Hospital, Vaasa, Finland

Registry information

Official study title

A Randomized Prospective Three-center Study: Laparoscopic Gastric Bypass vs. Laparoscopic Sleeve Gastrectomy in the Treatment of Morbid Obesity

Acronym: SLEEVEPASS

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Nov 19, 2008
Registry last updated
Aug 24, 2017

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.

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