Clinical trial NCT01373892: Prospective, Randomised Study: Metabolic and Functional Effects of Bariatric Surgery Accessed Using PET and MRI.
Official title: Prospective, Randomised Study: Metabolic and Functional Effects of Bariatric Surgery Accessed Using PET and MRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2011-06-15
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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

Eligibility criteria: Inclusion Criteria:

* 1) BMI \> 40 kg/m2 or

Primary outcomes:
measure: Tissue metabolism among morbidly obese persons assessed using PET, MRI and fMRI
timeFrame: Imaging studies will be performed before the bariatric surgery (day 1) and 6 months after. Healthy volunteers will be studied only once.
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku PET Centre
Study officials:
References:
citation: Dadson P, Rebelos E, Honka H, Juarez-Orozco LE, Kalliokoski KK, Iozzo P, Teuho J, Salminen P, Pihlajamaki J, Hannukainen JC, Nuutila P. Change in abdominal, but not femoral subcutaneous fat CT-radiodensity is associated with improved metabolic profile after bariatric surgery. Nutr Metab Cardiovasc Dis. 2020 Nov 27;30(12):2363-2371. doi: 10.1016/j.numecd.2020.07.010. Epub 2020 Jul 15.
citation: Savolainen AM, Karmi A, Immonen H, Soinio M, Saunavaara V, Pham T, Salminen P, Helmio M, Ovaska J, Loyttyniemi E, Heiskanen MA, Lehtimaki T, Mari A, Nuutila P, Hannukainen JC. Physical Activity Associates with Muscle Insulin Sensitivity Postbariatric Surgery. Med Sci Sports Exerc. 2019 Feb;51(2):278-287. doi: 10.1249/MSS.0000000000001778.
citation: Immonen H, Hannukainen JC, Kudomi N, Pihlajamaki J, Saunavaara V, Laine J, Salminen P, Lehtimaki T, Pham T, Iozzo P, Nuutila P. Increased Liver Fatty Acid Uptake Is Partly Reversed and Liver Fat Content Normalized After Bariatric Surgery. Diabetes Care. 2018 Feb;41(2):368-371. doi: 10.2337/dc17-0738. Epub 2017 Nov 20.
citation: Honka H, Koffert J, Hannukainen JC, Tuulari JJ, Karlsson HK, Immonen H, Oikonen V, Tolvanen T, Soinio M, Salminen P, Kudomi N, Mari A, Iozzo P, Nuutila P. The effects of bariatric surgery on pancreatic lipid metabolism and blood flow. J Clin Endocrinol Metab. 2015 May;100(5):2015-23. doi: 10.1210/jc.2014-4236. Epub 2015 Mar 3.
citation: Tuulari JJ, Karlsson HK, Hirvonen J, Salminen P, Nuutila P, Nummenmaa L. Neural circuits for cognitive appetite control in healthy and obese individuals: an fMRI study. PLoS One. 2015 Feb 6;10(2):e0116640. doi: 10.1371/journal.pone.0116640. eCollection 2015.
citation: Honka H, Hannukainen JC, Tarkia M, Karlsson H, Saunavaara V, Salminen P, Soinio M, Mikkola K, Kudomi N, Oikonen V, Haaparanta-Solin M, Roivainen A, Parkkola R, Iozzo P, Nuutila P. Pancreatic metabolism, blood flow, and beta-cell function in obese humans. J Clin Endocrinol Metab. 2014 Jun;99(6):E981-90. doi: 10.1210/jc.2013-4369. Epub 2014 Feb 14.