Prospective, Randomised Study: Metabolic and Functional Effects of Bariatric Surgery Accessed Using PET and MRI.

Not Applicable

Completed

• Conditions: Morbid Obesity
• Interventions: Procedure: Bariatric surgery

• Registration Number: NCT01373892
• Lead Sponsor: Turku University Hospital

Brief Summary

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. 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 are studied with PET and 14(R, S)-\[18F\]-fluoro-6-thia-heptadecanoic acid (\[18F\]FTHA). Changes in body fat distribution are investigated with magnetic resonance imaging (MRI) 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.

Detailed Description

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

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-06-07
• Study First Submitted QC: 2011-06-14
• Study First Posted: 2011-06-15
• Primary Completion: 2013-12
• Study Completion: 2016-01
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-05
• Last Update Posted: 2017-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• 1. BMI > 40 kg/m2 or

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgery	Bariatric surgery	Slevve vs. Roux-Y

Primary Outcome Measures

Name	Time	Method
Tissue metabolism among morbidly obese persons assessed using PET, MRI and fMRI	Imaging studies will be performed before the bariatric surgery (day 1) and 6 months after. Healthy volunteers will be studied only once.

Trial Locations

Locations (1)

Turku PET Centre; 🇫🇮 Turku, Finland