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Sleevepet2: Prospective, Randomised Study: Metabolic and Functional Effects of Bariatric Surgery Accessed Using PET and MRI.

Sponsor
Turku University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01373892
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
60
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Bariatric surgery
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Masking Description:
Sleeve or gastric bypass operation for obese
Primary Purpose:
Basic Science
Official Title:
Prospective, Randomised Study: Metabolic and Functional Effects of Bariatric Surgery Accessed Using PET and MRI
Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Jan 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Surgery

Slevve vs. Roux-Y

Procedure: Bariatric surgery
No Intervention: Healthy lean volunteers

Outcome Measures

Primary Outcome Measures

  1. 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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
    1. BMI > 40 kg/m2 or

Contacts and Locations

Locations

Site City State Country Postal Code
1 Turku PET Centre Turku Finland 20520

Sponsors and Collaborators

  • Turku University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pirjo Nuutila, professor, cheif physician, Turku University Hospital
ClinicalTrials.gov Identifier:
NCT01373892
Other Study ID Numbers:
  • Sleevepet2
First Posted:
Jun 15, 2011
Last Update Posted:
Mar 7, 2017
Last Verified:
Mar 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Obesity, Morbid

Study Results

No Results Posted as of Mar 7, 2017