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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01373892
Acronym
Sleevepet2
Enrollment
50
Registered
2011-06-15
Start date
2011-01-31
Completion date
2016-01-31
Last updated
2017-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid Obesity

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

Interventions

PROCEDUREBariatric surgery

Sponsors

Turku University Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Masking description

Sleeve or gastric bypass operation for obese

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* 1\) BMI \> 40 kg/m2 or

Design outcomes

Primary

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

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026