Prospective, Randomised Study: Metabolic and Functional Effects of Bariatric Surgery Accessed Using Positron Emission Tomography (PET) and MRI. (Sleevepet2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2010 by Turku University Hospital
Sponsor:
Information provided by:
Turku University Hospital
ClinicalTrials.gov Identifier:
NCT01373892
First received: June 7, 2011
Last updated: June 14, 2011
Last verified: September 2010
  Purpose

Diet and nutrition are important factors in the maintenance of good health throughout the entire life course. Their role as determinants of chronic diseases such as obesity, diabetes and cardiovascular diseases is well established. The annual increase in the prevalence and the severity of obesity in both adults and children is currently substantial, and in Finland 40% of adults are overweight or obese. Identifying the mechanisms that make some individuals vulnerable to overeating, as well as pinpointing how obesity changes the functioning of the human mental and bodily functions would be critical for understanding the current high prevalence of obesity.

Animal studies suggest that the brain extensively coordinates the adaptive mechanisms and the alterations of energy intake and expenditure. Accumulating evidence suggest that obesity is associated with changes in brain morphology and function, thus the source for obesity may lie in the brain. In the present project the investigators test this hypothesis by implementing a multimodal neuroimaging approach with positron emission tomography (PET), functional magnetic resonance imaging (fMRI), diffusion tensor imaging (DTI) and voxel-based morphometry (VBM). By studying brain anatomy and function in lean individuals as well as obese patients undergoing weight loss surgery, the investigators can evaluate whether the observed differences between lean and obese individuals are causes or consequences of obesity. In PET imaging of the brain, the investigators will focus on two specific neurotransmitter systems, dopamine and opioid, which are largely been unexplored in obesity research.

Obesity is related to elevated plasma glucose levels and endothelial dysfunction. Elevated plasma glucose and endothelial dysfunction are known risk factors for diabetes and coronary heart disease.

Weight reduction modifies risk factors such as blood pressure and lipid profile for chronic diseases. On this study the investigators are able to further investigate changes in fatty acid metabolism and hormones affecting feeding and energy balance. In addition, changes in brain activation in response to food stimuli will be assessed. As far as the investigators know there are no previous positron emission tomography (PET) studies that investigate these risk factor variables from one study population pre-operatively and after bariatric surgery.

The objectives of this study are to measure effect of obesity on brain structure and molecular pathways, food-stimuli mediated brain activation response, on hormones affecting both feeding and energy balance as well as on bone metabolism and bone marrow fat. The study consists of two phases. In the first phase the studies are performed at baseline before bariatric surgery and in the second phase post-operatively after 6 months. Regional free fatty acid uptake in myocardium, skeletal muscle, subcutaneous fat, visceral fat, pancreas, liver, brain, intestine and the bone are studied with PET and 14(R, S)-[18F]-fluoro-6-thia-heptadecanoic acid ([18F]FTHA). 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). ). Cardiac functioning is studied with echocardiography and functional MRI (fMRI) and ectopic fat in and around the heart using MRI and 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). Brain neurotransmitter system will be measured with [11C]raclopride and [11C]carfentanil and PET. In the second part of the study the same variables are studied after bariatric surgery: either laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass. 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 changes in tissue metabolism between these two surgical procedures.

The study consists totally of 60 study subjects. Of these 40 are morbidly obese adults, BMI


Condition Intervention
Morbid Obesity
Procedure: Bariatric surgery

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Prospective, Randomised Study: Metabolic and Functional Effects of Bariatric Surgery Accessed Using PET and MRI

Resource links provided by NLM:


Further study details as provided by Turku University Hospital:

Primary Outcome Measures:
  • Tissue metabolism among morbidly obese persons assessed using PET, MRI and fMRI [ Time Frame: Imaging studies will be performed before the bariatric surgery (day 1) and 6 months after. Healthy volunteers will be studied only once. ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Surgery Procedure: Bariatric surgery
No Intervention: Healthy lean volunteers

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 1) BMI > 40 kg/m2 or
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01373892

Locations
Finland
Turku PET Centre Recruiting
Turku, Finland, 20520
Contact: Pirjo Nuutila, Professor    +358 2 2611 868    pirnuu@utu.fi   
Sponsors and Collaborators
Turku University Hospital
  More Information

No publications provided by Turku University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pirjo Nuutila, Turku PET Centre
ClinicalTrials.gov Identifier: NCT01373892     History of Changes
Other Study ID Numbers: Sleevepet2
Study First Received: June 7, 2011
Last Updated: June 14, 2011
Health Authority: Finland: Ethical Committee of the Hospital District of the South-Western Finland

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014