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Clinical Trials/NCT01373892
NCT01373892
Completed
Not Applicable

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

Turku University Hospital1 site in 1 country50 target enrollmentJanuary 2011
ConditionsMorbid Obesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Morbid Obesity
Sponsor
Turku University Hospital
Enrollment
50
Locations
1
Primary Endpoint
Tissue metabolism among morbidly obese persons assessed using PET, MRI and fMRI
Status
Completed
Last Updated
9 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
January 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pirjo Nuutila

professor, cheif physician

Turku University Hospital

Eligibility Criteria

Inclusion Criteria

  • BMI \> 40 kg/m2 or

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

Study Sites (1)

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