NCT00793143

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2008

Typical duration for all trials

Geographic Reach
1 country

4 active sites

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

April 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 19, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

August 24, 2017

Status Verified

August 1, 2017

Enrollment Period

2.1 years

First QC Date

November 17, 2008

Last Update Submit

August 22, 2017

Conditions

Morbid Obesity

Keywords

morbid obesitylaparoscopic sleeve gastrectomyLSGlaparoscopic gastric bypassLGBcomorbiditiesdiabetesexcessive weight lossweight loss

Outcome Measures

Primary Outcomes (1)

  • Excessive weight loss

    3,6,12,18 months, 2,3,5,7,10,15 years

Secondary Outcomes (4)

  • Resolution of comorbidities

    3,6,12,18 months, 2,3,5,7,10,15 years

  • Mortality

    0 - 15 years

  • Morbidity

    0 - 15 years

  • QOL (15D and BAROS)

    3,6,12,18 months, 2,3,5,7,10,15 years

Study Arms (2)

Sleeve

Bypass

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients rederred to three tertiary referral hospitals (Turku University Central Hospital, Vaasa Central Hospital and Peijas Hospital)for treatment of morbid obesity

You may qualify if:

  • 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

You may not qualify if:

  • BMI \> 60
  • Difficult psychiatric conditions or lack of co-operation
  • Difficult eating disorder (binge eating, bulimia etc.)
  • Alcohol abuse
  • Gastric ulcer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Helsinki University Hospital

Helsinki, Finland

Location

Department of Surgery, Turku University Central Hospital

Turku, 20520, Finland

Location

Turku University Hospital, PET-center

Turku, Finland

Location

Vaasa Central Hospital

Vaasa, Finland

Location

Related Publications (15)

  • 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

  • Saarinen 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.

    PMID: 40613787DERIVED

  • 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

  • Saarinen 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.

    PMID: 39509008DERIVED

  • Peterli 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.

    PMID: 38055284DERIVED

  • Saux 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.

    PMID: 37652841DERIVED

  • Salminen 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.

    PMID: 35731535DERIVED

  • Gronroos 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.

    PMID: 33295955DERIVED

  • Pham 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.

    PMID: 32311037DERIVED

  • 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

  • Salminen 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.

    PMID: 29340676DERIVED

  • 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

  • Immonen 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.

    PMID: 24060855DERIVED

  • Tuulari JJ, Karlsson HK, Hirvonen J, Hannukainen JC, Bucci M, Helmio M, Ovaska J, Soinio M, Salminen P, Savisto N, Nummenmaa L, Nuutila P. Weight loss after bariatric surgery reverses insulin-induced increases in brain glucose metabolism of the morbidly obese. Diabetes. 2013 Aug;62(8):2747-51. doi: 10.2337/db12-1460. Epub 2013 Mar 14.

    PMID: 23493575DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Tissue samples

MeSH Terms

Conditions

Obesity, MorbidDiabetes MellitusWeight Loss

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesBody Weight Changes

Study Officials

  • Paulina Salminen, MD, PhD

    Turku Univeristy Central Hospital

    PRINCIPAL INVESTIGATOR

  • Jari Ovaska, Md, PhD

    University of Turku

    PRINCIPAL INVESTIGATOR

  • Mikael Victorzon, MD, PhD

    Vaasa Central Hospital, Vaasa, Finland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 17, 2008

First Posted

November 19, 2008

Study Start

April 1, 2008

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

August 24, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

FI(4)