Morbid ObesitySLEEVEPASSNCT00793143
Laparoscopic Gastric Bypass Versus Sleeve Gastrectomy to Treat Morbid Obesity
An observational study of Morbid Obesity, run by Turku University Hospital at 4 sites in Finland.
Trial summary
Bariatric surgery in the treatment of morbid obesity is associated with long-term weight-loss and decreased overall mortality. Long-term results have been reported for laparoscopic gastric bypass procedures but the long-term results of laparoscopic sleeve gastrectomy are yet unavailable. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Morbid Obesity
- How many people
- 240 participants
- Where
- 4 sitesFinland
- Study dates
- Apr 2008to May 2010
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult
Study population: Patients rederred to three tertiary referral hospitals (Turku University Central Hospital, Vaasa Central Hospital and Peijas Hospital)for treatment of morbid obesity
Who may be able to join
- BMI > 40 or BMI > 35 with a comorbidity associated with obesity
- Age 18 - 60 years
- Failed prior effective and controlled conservative treatments of morbid obesity
Who cannot join
- BMI > 60
- Difficult psychiatric conditions or lack of co-operation
- Difficult eating disorder (binge eating, bulimia etc.)
- Alcohol abuse
- Gastric ulcer
Trial locations and contacts
4 sites in 1 country.
Finland4 sites
Helsinki University Hospital
Helsinki
Department of Surgery, Turku University Central Hospital
Turku, 20520
Turku University Hospital, PET-center
Turku
Vaasa Central Hospital
Vaasa
About this study
Official title: A Randomized Prospective Three-center Study: Laparoscopic Gastric Bypass vs. Laparoscopic Sleeve Gastrectomy in the Treatment of Morbid Obesity
Bariatric surgery in the treatment of morbid obesity is associated with long-term weight-loss and decreased overall mortality. Long-term results have been reported for laparoscopic gastric bypass procedures but the long-term results of laparoscopic sleeve gastrectomy are yet unavailable. As sleeve gastrectomy is a rapid and less traumatic procedure with good short-term results of weight loss and resolution of comorbidities, the investigators initiated a prospective randomized two-center study comparing laparoscopic sleeve gastrectomy (LSG)with laparoscopic gastric bypass (LGB) in the treatment of morbid obesity. Study hypothesis: As sleeve gastrectomy is less traumatic, easier and faster to perform compared with gastric bypass,LSG could become the procedure of choice to treat morbid obesity if the long-term results of weight loss and resolution of comorbidities are comparable with laparoscopic gastric bypass.
Read the detailed description
In addition to comparing the outcomes between sleeve gastrectomy and gastric bypass, the study project includes a PET trial conducted in Turku. The objectives of this PET study are to measure effect of obesity on food-stimuli mediated brain activation response and on hormones affecting both feeding and energy balance. In the second part the same variables are studied after bariatric surgery: either laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass. In addition the effect of weight loss due to bariatric surgery on glucose uptake and free fatty acid metabolism is measured. The objective is also to study whether less invasive sleeve gastrectomy is as beneficial in terms of weight loss and co-morbid diseases as more invasive Roux-en-Y gastric bypass and to compare the risk factors between these two surgical procedures. Regional glucose uptake and free fatty acid uptake in myocardium, skeletal muscle, subcutaneous fat, visceral fat, pancreas, liver and brain are studied with PET at baseline before bariatric surgery and post-operatively on the 3rd month. Changes in body fat distribution, in ectopic fat and fat content of key organs 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 of 80 morbidly obese adults, BMI ≥ 40 kg/m2 or if there is additional risk factor BMI ≥ 35 kg/m2. From these subjects, 40 are further studied with positron emission tomography (PET) and magnetic resonance imaging (MRI). In addition functional MRI (fMRI) will be performed for 40 subjects. For fMRI, a control group is recruited consisting of 20 lean and healthy subjects. Subjects are physically examined and anthropometric data are measured along with blood sampling.
- Conditions
- Morbid Obesity
- Keywords
- morbid obesity, laparoscopic sleeve gastrectomy, LSG, laparoscopic gastric bypass, LGB, comorbidities, diabetes, excessive weight loss, weight loss
- Medical subject headings
- Obesity, Morbid, Diabetes Mellitus, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sleeve | Not described | |
| Bypass | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excessive weight loss
Measured: 3,6,12,18 months, 2,3,5,7,10,15 years
Secondary outcomes (4)
Resolution of comorbidities
Measured: 3,6,12,18 months, 2,3,5,7,10,15 years
Mortality
Measured: 0 - 15 years
Morbidity
Measured: 0 - 15 years
QOL (15D and BAROS)
Measured: 3,6,12,18 months, 2,3,5,7,10,15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startApr 2008
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- Vaasa Central Hospital, Vaasa, Finland, Helsinki University Central Hospital
- Responsible party
- Principal investigator, Paulina Salminen, Turku University Hospital
- Investigators
- Paulina Salminen, MD, PhD, Principal investigator, Turku Univeristy Central HospitalJari Ovaska, Md, PhD, Principal investigator, University of TurkuMikael Victorzon, MD, PhD, Principal investigator, Vaasa Central Hospital, Vaasa, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00793143
- Sponsor's protocol ID
- SLEEVEPASS
- Acronym
- SLEEVEPASS
- Status last verified
- Aug 2017
- First submitted
- 17 Nov 2008
- Last updated
- 24 Aug 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 42888206Dadson 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 41077621Dadson 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 40854969Saarinen I, Strandberg M, Hurme S, Helmio M, Gronroos S, Juuti A, Juusela R, Nuutila P, Salminen P. Nutritional deficiencies after sleeve gastrectomy and Roux-en-Y gastric bypass at 10 years: secondary analysis of the SLEEVEPASS randomized clinical trial. Br J Surg. 2025 Jul 3;112(7):znaf132. doi: 10.1093/bjs/znaf132.
PubMed 40613787Dadson 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 39819027Saarinen I, Strandberg M, Hurme S, Gronroos S, Juuti A, Helmio M, Salminen P. Association of High-Sensitivity C-Reactive Protein (hs-CRP) with Weight Loss After Sleeve Gastrectomy and Roux-en-Y Gastric Bypass at 10 Years: A Secondary Analysis of the SLEEVEPASS Randomized Clinical Trial. Obes Surg. 2024 Dec;34(12):4378-4384. doi: 10.1007/s11695-024-07567-w. Epub 2024 Nov 7.
PubMed 39509008Peterli R, Hurme S, Bueter M, Gronroos S, Helmio M, Salminen P. Standardized Assessment of Metabolic Bariatric Surgery Outcomes: Secondary Analysis of 2 Randomized Clinical Trials. JAMA Surg. 2024 Mar 1;159(3):306-314. doi: 10.1001/jamasurg.2023.6254.
PubMed 38055284Saux P, Bauvin P, Raverdy V, Teigny J, Verkindt H, Soumphonphakdy T, Debert M, Jacobs A, Jacobs D, Monpellier V, Lee PC, Lim CH, Andersson-Assarsson JC, Carlsson L, Svensson PA, Galtier F, Dezfoulian G, Moldovanu M, Andrieux S, Couster J, Lepage M, Lembo E, Verrastro O, Robert M, Salminen P, Mingrone G, Peterli R, Cohen RV, Zerrweck C, Nocca D, Le Roux CW, Caiazzo R, Preux P, Pattou F. Development and validation of an interpretable machine learning-based calculator for predicting 5-year weight trajectories after bariatric surgery: a multinational retrospective cohort SOPHIA study. Lancet Digit Health. 2023 Oct;5(10):e692-e702. doi: 10.1016/S2589-7500(23)00135-8. Epub 2023 Aug 29.
PubMed 37652841Salminen P, Gronroos S, Helmio M, Hurme S, Juuti A, Juusela R, Peromaa-Haavisto P, Leivonen M, Nuutila P, Ovaska J. Effect of Laparoscopic Sleeve Gastrectomy vs Roux-en-Y Gastric Bypass on Weight Loss, Comorbidities, and Reflux at 10 Years in Adult Patients With Obesity: The SLEEVEPASS Randomized Clinical Trial. JAMA Surg. 2022 Aug 1;157(8):656-666. doi: 10.1001/jamasurg.2022.2229.
PubMed 35731535Gronroos S, Helmio M, Juuti A, Tiusanen R, Hurme S, Loyttyniemi E, Ovaska J, Leivonen M, Peromaa-Haavisto P, Maklin S, Sintonen H, Sammalkorpi H, Nuutila P, Salminen P. Effect of Laparoscopic Sleeve Gastrectomy vs Roux-en-Y Gastric Bypass on Weight Loss and Quality of Life at 7 Years in Patients With Morbid Obesity: The SLEEVEPASS Randomized Clinical Trial. JAMA Surg. 2021 Feb 1;156(2):137-146. doi: 10.1001/jamasurg.2020.5666.
PubMed 33295955Pham TT, Ivaska KK, Hannukainen JC, Virtanen KA, Lidell ME, Enerback S, Makela K, Parkkola R, Piirola S, Oikonen V, Nuutila P, Kiviranta R. Human Bone Marrow Adipose Tissue is a Metabolically Active and Insulin-Sensitive Distinct Fat Depot. J Clin Endocrinol Metab. 2020 Jul 1;105(7):2300-10. doi: 10.1210/clinem/dgaa216.
PubMed 32311037Savolainen 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 30247434Salminen P, Helmio M, Ovaska J, Juuti A, Leivonen M, Peromaa-Haavisto P, Hurme S, Soinio M, Nuutila P, Victorzon M. Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss at 5 Years Among Patients With Morbid Obesity: The SLEEVEPASS Randomized Clinical Trial. JAMA. 2018 Jan 16;319(3):241-254. doi: 10.1001/jama.2017.20313.
PubMed 29340676Honka 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 24527718Immonen H, Hannukainen JC, Iozzo P, Soinio M, Salminen P, Saunavaara V, Borra R, Parkkola R, Mari A, Lehtimaki T, Pham T, Laine J, Karja V, Pihlajamaki J, Nelimarkka L, Nuutila P. Effect of bariatric surgery on liver glucose metabolism in morbidly obese diabetic and non-diabetic patients. J Hepatol. 2014 Feb;60(2):377-83. doi: 10.1016/j.jhep.2013.09.012. Epub 2013 Sep 20.
PubMed 24060855
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Prospective Three-center Study: Laparoscopic Gastric Bypass vs. Laparoscopic Sleeve Gastrectomy in the Treatment of Morbid Obesity
- ClinicalTrials.gov ID
- NCT00793143
- Acronym / sponsor ID
- SLEEVEPASS / SLEEVEPASS
- Conditions
- Morbid Obesity
- Keywords
- morbid obesity, laparoscopic sleeve gastrectomy, LSG, laparoscopic gastric bypass, LGB, comorbidities, diabetes, excessive weight loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- Vaasa Central Hospital, Vaasa, Finland, Helsinki University Central Hospital
- Study start
- Apr 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 19 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bariatric surgery in the treatment of morbid obesity is associated with long-term weight-loss and decreased overall mortality. Long-term results have been reported for laparoscopic gastric bypass procedures but the long-term results of laparoscopic sleeve gastrectomy are yet unavailable. As sleeve gastrectomy is a rapid and less traumatic procedure with good short-term results of weight loss and resolution of comorbidities, the investigators initiated a prospective randomized two-center study comparing laparoscopic sleeve gastrectomy (LSG)with laparoscopic gastric bypass (LGB) in the treatment of morbid obesity. Study hypothesis: As sleeve gastrectomy is less traumatic, easier and faster to perform compared with gastric bypass,LSG could become the procedure of choice to treat morbid obesity if the long-term results of weight loss and resolution of comorbidities are comparable with laparoscopic gastric bypass.
Detailed description
In addition to comparing the outcomes between sleeve gastrectomy and gastric bypass, the study project includes a PET trial conducted in Turku. The objectives of this PET study are to measure effect of obesity on food-stimuli mediated brain activation response and on hormones affecting both feeding and energy balance. In the second part the same variables are studied after bariatric surgery: either laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass. In addition the effect of weight loss due to bariatric surgery on glucose uptake and free fatty acid metabolism is measured. The objective is also to study whether less invasive sleeve gastrectomy is as beneficial in terms of weight loss and co-morbid diseases as more invasive Roux-en-Y gastric bypass and to compare the risk factors between these two surgical procedures. Regional glucose uptake and free fatty acid uptake in myocardium, skeletal muscle, subcutaneous fat, visceral fat, pancreas, liver and brain are studied with PET at baseline before bariatric surgery and post-operatively on the 3rd month. Changes in body fat distribution, in ectopic fat and fat content of key organs 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 of 80 morbidly obese adults, BMI ≥ 40 kg/m2 or if there is additional risk factor BMI ≥ 35 kg/m2. From these subjects, 40 are further studied with positron emission tomography (PET) and magnetic resonance imaging (MRI). In addition functional MRI (fMRI) will be performed for 40 subjects. For fMRI, a control group is recruited consisting of 20 lean and healthy subjects. Subjects are physically examined and anthropometric data are measured along with blood sampling.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleeve | – | – |
| Bypass | – | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients rederred to three tertiary referral hospitals (Turku University Central Hospital, Vaasa Central Hospital and Peijas Hospital)for treatment of morbid obesity
Key inclusion criteria (3 listed)
- BMI > 40 or BMI > 35 with a comorbidity associated with obesity
- Age 18 - 60 years
- Failed prior effective and controlled conservative treatments of morbid obesity
Key exclusion criteria (5 listed)
- BMI > 60
- Difficult psychiatric conditions or lack of co-operation
- Difficult eating disorder (binge eating, bulimia etc.)
- Alcohol abuse
- Gastric ulcer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Excessive weight loss
Time frame: 3,6,12,18 months, 2,3,5,7,10,15 years
4 secondary outcomes
Resolution of comorbidities
Time frame: 3,6,12,18 months, 2,3,5,7,10,15 years
Mortality
Time frame: 0 - 15 years
Morbidity
Time frame: 0 - 15 years
QOL (15D and BAROS)
Time frame: 3,6,12,18 months, 2,3,5,7,10,15 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
- Derived from this study: PubMed 42888206Dadson 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.
- Derived from this study: PubMed 41077621Dadson 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.
- Derived from this study: PubMed 40854969Dadson 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.
- Derived from this study: PubMed 40613787Saarinen I, Strandberg M, Hurme S, Helmio M, Gronroos S, Juuti A, Juusela R, Nuutila P, Salminen P. Nutritional deficiencies after sleeve gastrectomy and Roux-en-Y gastric bypass at 10 years: secondary analysis of the SLEEVEPASS randomized clinical trial. Br J Surg. 2025 Jul 3;112(7):znaf132. doi: 10.1093/bjs/znaf132.
- Derived from this study: PubMed 39819027Dadson 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.
- Derived from this study: PubMed 39509008Saarinen I, Strandberg M, Hurme S, Gronroos S, Juuti A, Helmio M, Salminen P. Association of High-Sensitivity C-Reactive Protein (hs-CRP) with Weight Loss After Sleeve Gastrectomy and Roux-en-Y Gastric Bypass at 10 Years: A Secondary Analysis of the SLEEVEPASS Randomized Clinical Trial. Obes Surg. 2024 Dec;34(12):4378-4384. doi: 10.1007/s11695-024-07567-w. Epub 2024 Nov 7.
- Derived from this study: PubMed 38055284Peterli R, Hurme S, Bueter M, Gronroos S, Helmio M, Salminen P. Standardized Assessment of Metabolic Bariatric Surgery Outcomes: Secondary Analysis of 2 Randomized Clinical Trials. JAMA Surg. 2024 Mar 1;159(3):306-314. doi: 10.1001/jamasurg.2023.6254.
- Derived from this study: PubMed 37652841Saux P, Bauvin P, Raverdy V, Teigny J, Verkindt H, Soumphonphakdy T, Debert M, Jacobs A, Jacobs D, Monpellier V, Lee PC, Lim CH, Andersson-Assarsson JC, Carlsson L, Svensson PA, Galtier F, Dezfoulian G, Moldovanu M, Andrieux S, Couster J, Lepage M, Lembo E, Verrastro O, Robert M, Salminen P, Mingrone G, Peterli R, Cohen RV, Zerrweck C, Nocca D, Le Roux CW, Caiazzo R, Preux P, Pattou F. Development and validation of an interpretable machine learning-based calculator for predicting 5-year weight trajectories after bariatric surgery: a multinational retrospective cohort SOPHIA study. Lancet Digit Health. 2023 Oct;5(10):e692-e702. doi: 10.1016/S2589-7500(23)00135-8. Epub 2023 Aug 29.
- Derived from this study: PubMed 35731535Salminen P, Gronroos S, Helmio M, Hurme S, Juuti A, Juusela R, Peromaa-Haavisto P, Leivonen M, Nuutila P, Ovaska J. Effect of Laparoscopic Sleeve Gastrectomy vs Roux-en-Y Gastric Bypass on Weight Loss, Comorbidities, and Reflux at 10 Years in Adult Patients With Obesity: The SLEEVEPASS Randomized Clinical Trial. JAMA Surg. 2022 Aug 1;157(8):656-666. doi: 10.1001/jamasurg.2022.2229.
- Derived from this study: PubMed 33295955Gronroos S, Helmio M, Juuti A, Tiusanen R, Hurme S, Loyttyniemi E, Ovaska J, Leivonen M, Peromaa-Haavisto P, Maklin S, Sintonen H, Sammalkorpi H, Nuutila P, Salminen P. Effect of Laparoscopic Sleeve Gastrectomy vs Roux-en-Y Gastric Bypass on Weight Loss and Quality of Life at 7 Years in Patients With Morbid Obesity: The SLEEVEPASS Randomized Clinical Trial. JAMA Surg. 2021 Feb 1;156(2):137-146. doi: 10.1001/jamasurg.2020.5666.
- Derived from this study: PubMed 32311037Pham TT, Ivaska KK, Hannukainen JC, Virtanen KA, Lidell ME, Enerback S, Makela K, Parkkola R, Piirola S, Oikonen V, Nuutila P, Kiviranta R. Human Bone Marrow Adipose Tissue is a Metabolically Active and Insulin-Sensitive Distinct Fat Depot. J Clin Endocrinol Metab. 2020 Jul 1;105(7):2300-10. doi: 10.1210/clinem/dgaa216.
- Derived from this study: PubMed 30247434Savolainen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paulina Salminen, MD, PhD principal investigator
Turku Univeristy Central Hospital
Jari Ovaska, Md, PhD principal investigator
University of Turku
Mikael Victorzon, MD, PhD principal investigator
Vaasa Central Hospital, Vaasa, Finland
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morbid Obesity, run by Turku University Hospital at 4 sites 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 3 inclusion and 5 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 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Excessive weight loss (time frame: 3,6,12,18 months, 2,3,5,7,10,15 years). 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 NCT00793143, which also lists 16 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 24 Aug 2017.