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Morbid ObesitySleevepet2NCT01373892

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

A study testing Bariatric surgery in people with Morbid Obesity, run by Turku University Hospital at 1 site in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for
Morbid Obesity
What is being tested?
Bariatric surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteFinland
Study dates
Jan 2011to Jan 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 1) BMI > 40 kg/m2 or

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Finland1 site

  • Turku PET Centre

    Turku, Turku, 20520

Other trials in Finland

About this study

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

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.

Read the 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
Being tested
Bariatric surgery
Medical subject headings
Obesity, Morbid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bariatric surgeryProcedure or surgery

Study groups in NCT01373892
Study groupRoleWhat they receive
SurgeryActive comparatorSlevve vs. Roux-Y
Receives: Procedure: Bariatric surgery
Healthy lean volunteersNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tissue metabolism among morbidly obese persons assessed using PET, MRI and fMRI

    Measured: Imaging studies will be performed before the bariatric surgery (day 1) and 6 months after. Healthy volunteers will be studied only once.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2011 (estimated)
  2. Study startJan 2011
  3. Primary completionDec 2013
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01373892
Sponsor's protocol ID
Sleevepet2
Acronym
Sleevepet2
Status last verified
Mar 2017
First submitted
7 Jun 2011
Last updated
7 Mar 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Dadson P, Jaakkola MK, Sun L, Klen R, Suomi T, Vaittinen M, Anastasiou IA, Honka H, Immonen H, Badeau RM, Salminen P, Helmio M, Roivainen A, Pekkarinen L, Kalliokoski KK, Rebelos E, Olkkonen VM, Nuutila P. Adipose tissue transcriptome before and after surgery: effects on genes driving lipid metabolism, inflammation, and RNA processing. Int J Obes (Lond). 2026 Oct 16. doi: 10.1038/s41366-026-02243-8. Online ahead of print.

    PubMed 42888206

  • 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). 2026 Jan;34(1):127-137. doi: 10.1002/oby.70041. Epub 2025 Oct 12.

    PubMed 41077621

  • 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 Dec;49(12):2494-2502. doi: 10.1038/s41366-025-01888-1. Epub 2025 Aug 26.

    PubMed 40854969

  • 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.

    PubMed 39819027

  • 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.

    PubMed 32919861

  • 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.

    PubMed 30247434

  • 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.

    PubMed 29158250

  • 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.

    PubMed 25734253

  • 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.

    PubMed 25658479

  • 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.

    PubMed 24527718

Questions about this trial

What is this clinical trial studying?

A study testing Bariatric surgery in people with Morbid Obesity, run by Turku University Hospital at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01373892, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2017.

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