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

NCT ID: NCT01373892

Last Updated: 2017-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2016-01-31

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

Conditions

Morbid Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Surgery

Slevve vs. Roux-Y

Group Type: ACTIVE_COMPARATOR

Bariatric surgery

Intervention Type: PROCEDURE

Healthy lean volunteers

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Bariatric surgery

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 1) BMI > 40 kg/m2 or

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Turku University Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Pirjo Nuutila

professor, cheif physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Turku PET Centre

Turku, Turku, Finland

Countries

Finland

References

Dadson P, Honka MJ, Suomi T, Rokka A, Kauhanen S, Salminen P, Helmio M, James P, Elo LL, Olkkonen VM, Nuutila P. Characterization of Visceral Adipose Tissue Proteome Reveals Metabolic Changes and Inflammatory Signatures in Severe Obesity. Obesity (Silver Spring). 2025 Oct 12. doi: 10.1002/oby.70041. Online ahead of print.

Reference Type: DERIVED

PMID: 41077621 (View on PubMed)

Dadson P, Rebelos E, Jaakkola MK, Monfort-Pires M, Ojala R, Honka H, Kalliokoski KK, Klen R, Nuutila P, Ivaska KK. Differential associations of subcutaneous and visceral fat with bone turnover markers: A study on bariatric surgery patients with severe obesity and individuals without obesity. Int J Obes (Lond). 2025 Aug 26. doi: 10.1038/s41366-025-01888-1. Online ahead of print.

Reference Type: DERIVED

PMID: 40854969 (View on PubMed)

Dadson P, Honka MJ, Suomi T, Haridas PAN, Rokka A, Palani S, Goltseva E, Wang N, Roivainen A, Salminen P, James P, Olkkonen VM, Elo LL, Nuutila P. Proteomic profiling reveals alterations in metabolic and cellular pathways in severe obesity and following metabolic bariatric surgery. Am J Physiol Endocrinol Metab. 2025 Mar 1;328(3):E311-E324. doi: 10.1152/ajpendo.00220.2024. Epub 2025 Jan 17.

Reference Type: DERIVED

PMID: 39819027 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32919861 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30247434 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29158250 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25734253 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25658479 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24527718 (View on PubMed)

Other Identifiers

Sleevepet2

Identifier Type: -

Identifier Source: org_study_id