NCT01373892

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 15, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 7, 2017

Status Verified

March 1, 2017

Enrollment Period

2.9 years

First QC Date

June 7, 2011

Last Update Submit

March 5, 2017

Conditions

Morbid Obesity

Outcome Measures

Primary Outcomes (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.

Study Arms (2)

Surgery

ACTIVE COMPARATOR

Slevve vs. Roux-Y

Procedure: Bariatric surgery

Healthy lean volunteers

NO INTERVENTION

Interventions

Bariatric surgeryPROCEDURE
Surgery

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \) BMI \> 40 kg/m2 or

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku PET Centre

Turku, Turku, 20520, Finland

Location

Related Publications (9)

  • 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.

    PMID: 41077621DERIVED

  • 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.

    PMID: 40854969DERIVED

  • 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.

    PMID: 39819027DERIVED

  • 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.

    PMID: 32919861DERIVED

  • 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.

    PMID: 30247434DERIVED

  • 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.

    PMID: 29158250DERIVED

  • 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.

    PMID: 25734253DERIVED

  • 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.

    PMID: 25658479DERIVED

  • 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.

    PMID: 24527718DERIVED

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Sleeve or gastric bypass operation for obese
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor, cheif physician

Study Record Dates

First Submitted

June 7, 2011

First Posted

June 15, 2011

Study Start

January 1, 2011

Primary Completion

December 1, 2013

Study Completion

January 1, 2016

Last Updated

March 7, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)