NCT01479452

Brief Summary

The purpose of the Swedish Obese Subjects (SOS) study is to examine the long-term effects of bariatric surgery on overall mortality and obesity-related co-morbidities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4,047

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jan 1987

Longer than P75 for not_applicable obesity

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, 1987

Completed
18.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

November 22, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 24, 2011

Completed
Last Updated

November 24, 2011

Status Verified

November 1, 2011

Enrollment Period

18.8 years

First QC Date

November 22, 2011

Last Update Submit

November 23, 2011

Conditions

Keywords

obesitybariatric surgeryweight loss

Outcome Measures

Primary Outcomes (1)

  • Overall mortality

    The SOS study was started in 1987 and effect of bariatric surgery on overall mortality (primary endpoint) was reported in 2007. Cut off date for the analysis was November 1, 2005.

    10 years

Study Arms (2)

Bariatric surgery

OTHER

Bariatric surgery

Procedure: Bariatric surgery

Controls

OTHER

Usual care

Other: Usual care

Interventions

Gastric banding, vertical banded gastroplasty, gastric bypass

Bariatric surgery

Non-surgical obesity treatment

Controls

Eligibility Criteria

Age37 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 37-60 years and BMI ≥34 kg/m2 in men and ≥38 kg/m2 in women.

You may not qualify if:

  • Gastric ulcer during the past 6 months; ongoing malignancy
  • Active malignancy during the past 5 years
  • Myocardial infarction during the past 6 months
  • Bulimic eating pattern; drug or alcohol (\>0·75 L 40% liquor per week or corresponding amount of ethanol) abuse
  • Psychiatric or cooperative problems contraindicating bariatric surgery
  • Other contraindicating conditions (such as continuous glucocorticoid or anti-inflammatory treatment).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SOS secretariat, Vita Straket 15, Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

Related Publications (38)

  • Sjostrom L, Lindroos AK, Peltonen M, Torgerson J, Bouchard C, Carlsson B, Dahlgren S, Larsson B, Narbro K, Sjostrom CD, Sullivan M, Wedel H; Swedish Obese Subjects Study Scientific Group. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N Engl J Med. 2004 Dec 23;351(26):2683-93. doi: 10.1056/NEJMoa035622.

  • Sjostrom L, Narbro K, Sjostrom CD, Karason K, Larsson B, Wedel H, Lystig T, Sullivan M, Bouchard C, Carlsson B, Bengtsson C, Dahlgren S, Gummesson A, Jacobson P, Karlsson J, Lindroos AK, Lonroth H, Naslund I, Olbers T, Stenlof K, Torgerson J, Agren G, Carlsson LM; Swedish Obese Subjects Study. Effects of bariatric surgery on mortality in Swedish obese subjects. N Engl J Med. 2007 Aug 23;357(8):741-52. doi: 10.1056/NEJMoa066254.

  • Sjostrom L, Gummesson A, Sjostrom CD, Narbro K, Peltonen M, Wedel H, Bengtsson C, Bouchard C, Carlsson B, Dahlgren S, Jacobson P, Karason K, Karlsson J, Larsson B, Lindroos AK, Lonroth H, Naslund I, Olbers T, Stenlof K, Torgerson J, Carlsson LM; Swedish Obese Subjects Study. Effects of bariatric surgery on cancer incidence in obese patients in Sweden (Swedish Obese Subjects Study): a prospective, controlled intervention trial. Lancet Oncol. 2009 Jul;10(7):653-62. doi: 10.1016/S1470-2045(09)70159-7. Epub 2009 Jun 24.

  • Sjoholm K, Svensson PA, Andersson-Assarsson JC, Jacobson P, Ahlin S, Karlsson C, Carlsson B, Kristensson FM, Karlsson P, Peltonen M, Carlsson LMS, Taube M. Sex-specific associations between surgery-induced weight loss and cancer outcomes: A post hoc analysis of the prospective, controlled Swedish Obese Subjects study. PLoS Med. 2026 Jan 5;23(1):e1004876. doi: 10.1371/journal.pmed.1004876. eCollection 2026 Jan.

  • Carlsson LM, Peltonen M, Jacobson P, Andersson-Assarsson JC, Svensson PA, Taube M, Karlsson C, Ahlin S, Kristensson FM, Perkins R, Arnetorp I, Carlsson A, Admeus L, Langegard E, Carlsson B, Sjoholm K. Possible selection bias in register-based obesity studies. Eur J Epidemiol. 2025 Jul;40(7):759-766. doi: 10.1007/s10654-025-01237-6. Epub 2025 May 12.

  • Carlsson LMS, Arnetorp I, Andersson-Assarsson JC, Jacobson P, Svensson PA, Taube M, Ahlin S, Kristensson FM, Karason K, Larsson I, Karlsson C, Pietilainen KH, Naslund I, Carlsson B, Peltonen M, Sjoholm K. Health outcomes and their association with weight regain after substantial weight loss in Sweden: a prospective cohort study. Lancet Reg Health Eur. 2025 Mar 13;52:101261. doi: 10.1016/j.lanepe.2025.101261. eCollection 2025 May.

  • Carlsson LMS, Carlsson B, Jacobson P, Karlsson C, Andersson-Assarsson JC, Kristensson FM, Ahlin S, Svensson PA, Taube M, Naslund I, Karason K, Peltonen M, Sjoholm K. Mortality in relation to diabetes remission in Swedish Obese Subjects - a prospective cohort study. Int J Surg. 2024 Oct 1;110(10):6581-6590. doi: 10.1097/JS9.0000000000001807.

  • Kristensson FM, Andersson-Assarsson JC, Peltonen M, Jacobson P, Ahlin S, Svensson PA, Sjoholm K, Carlsson LMS, Taube M. Breast Cancer Risk After Bariatric Surgery and Influence of Insulin Levels: A Nonrandomized Controlled Trial. JAMA Surg. 2024 Aug 1;159(8):856-863. doi: 10.1001/jamasurg.2024.1169.

  • Sjoholm K, Andersson-Assarsson JC, Kristensson FM, Hjorth S, Garelius HG, Jacobson P, Svensson PA, Ahlin S, Carlsson B, Peltonen M, Carlsson LMS, Taube M. Long-term incidence of haematological cancer after bariatric surgery or usual care in the Swedish Obese Subjects study: a prospective cohort study. Lancet Healthy Longev. 2023 Oct;4(10):e544-e551. doi: 10.1016/S2666-7568(23)00141-1. Epub 2023 Sep 13.

  • Lohmander LS, Peltonen M, Andersson-Assarsson JC, Maglio C, Sjoholm K, Taube M, Jacobson P, Svensson PA, Carlsson LMS, Ahlin S. Bariatric surgery, osteoarthritis and arthroplasty of the hip and knee in Swedish Obese Subjects - up to 31 years follow-up of a controlled intervention study. Osteoarthritis Cartilage. 2023 May;31(5):636-646. doi: 10.1016/j.joca.2022.11.015. Epub 2023 Feb 6.

  • Sjoholm K, Carlsson LMS, Svensson PA, Andersson-Assarsson JC, Kristensson F, Jacobson P, Peltonen M, Taube M. Association of Bariatric Surgery With Cancer Incidence in Patients With Obesity and Diabetes: Long-term Results From the Swedish Obese Subjects Study. Diabetes Care. 2022 Feb 1;45(2):444-450. doi: 10.2337/dc21-1335.

  • Johansson K, Svensson PA, Soderling J, Peltonen M, Neovius M, Carlsson LMS, Sjoholm K. Long-term risk of anaemia after bariatric surgery: results from the Swedish Obese Subjects study. Lancet Diabetes Endocrinol. 2021 Aug;9(8):515-524. doi: 10.1016/S2213-8587(21)00141-8. Epub 2021 Jul 1.

  • Sjoholm K, Jacobson P, Taube M, Svensson PA, Andersson Assarsson JC, Carlsson LMS, Peltonen M. Long-term incidence of hypoglycaemia-related events after bariatric surgery or usual care in the Swedish Obese Subjects study: A register-based analysis. Diabetes Obes Metab. 2021 Aug;23(8):1917-1925. doi: 10.1111/dom.14420. Epub 2021 May 25.

  • Taube M, Peltonen M, Sjoholm K, Palmqvist R, Andersson-Assarsson JC, Jacobson P, Svensson PA, Carlsson LMS. Long-term incidence of colorectal cancer after bariatric surgery or usual care in the Swedish Obese Subjects study. PLoS One. 2021 Mar 25;16(3):e0248550. doi: 10.1371/journal.pone.0248550. eCollection 2021.

  • Carlsson LMS, Sjoholm K, Jacobson P, Andersson-Assarsson JC, Svensson PA, Taube M, Carlsson B, Peltonen M. Life Expectancy after Bariatric Surgery in the Swedish Obese Subjects Study. N Engl J Med. 2020 Oct 15;383(16):1535-1543. doi: 10.1056/NEJMoa2002449.

  • Jacobson P, Peltonen M, Svensson PA, Taube M, Andersson-Assarsson JC, Sjoholm K, Bouchard C, Carlsson B, Carlsson LMS. 9p21.3 Coronary Artery Disease Locus Identifies Patients With Treatment Benefit From Bariatric Surgery in the Nonrandomized Prospective Controlled Swedish Obese Subjects Study. Circ Genom Precis Med. 2020 Oct;13(5):460-465. doi: 10.1161/CIRCGEN.120.003113. Epub 2020 Sep 15.

  • Sjoholm K, Carlsson LMS, Taube M, le Roux CW, Svensson PA, Peltonen M. Comparison of Preoperative Remission Scores and Diabetes Duration Alone as Predictors of Durable Type 2 Diabetes Remission and Risk of Diabetes Complications After Bariatric Surgery: A Post Hoc Analysis of Participants From the Swedish Obese Subjects Study. Diabetes Care. 2020 Nov;43(11):2804-2811. doi: 10.2337/dc20-0157. Epub 2020 Sep 1.

  • Zhang Y, Peltonen M, Andersson-Assarsson JC, Svensson PA, Herder C, Rudin A, Carlsson L, Maglio C. Elevated adiponectin predicts the development of rheumatoid arthritis in subjects with obesity. Scand J Rheumatol. 2020 Nov;49(6):452-460. doi: 10.1080/03009742.2020.1753808. Epub 2020 Jul 15.

  • Ahlin S, Peltonen M, Sjoholm K, Anveden A, Jacobson P, Andersson-Assarsson JC, Taube M, Larsson I, Lohmander LS, Naslund I, Svensson PA, Carlsson LMS. Fracture risk after three bariatric surgery procedures in Swedish obese subjects: up to 26 years follow-up of a controlled intervention study. J Intern Med. 2020 May;287(5):546-557. doi: 10.1111/joim.13020. Epub 2020 Mar 3.

  • Kristensson FM, Andersson-Assarsson JC, Svensson PA, Carlsson B, Peltonen M, Carlsson LMS. Effects of Bariatric Surgery in Early- and Adult-Onset Obesity in the Prospective Controlled Swedish Obese Subjects Study. Diabetes Care. 2020 Apr;43(4):860-866. doi: 10.2337/dc19-1909. Epub 2020 Jan 23.

  • Taube M, Peltonen M, Sjoholm K, Anveden A, Andersson-Assarsson JC, Jacobson P, Svensson PA, Bergo MO, Carlsson LMS. Association of Bariatric Surgery With Skin Cancer Incidence in Adults With Obesity: A Nonrandomized Controlled Trial. JAMA Dermatol. 2020 Jan 1;156(1):38-43. doi: 10.1001/jamadermatol.2019.3240.

  • Maglio C, Zhang Y, Peltonen M, Andersson-Assarsson J, Svensson PA, Herder C, Rudin A, Carlsson L. Bariatric surgery and the incidence of rheumatoid arthritis - a Swedish Obese Subjects study. Rheumatology (Oxford). 2020 Feb 1;59(2):303-309. doi: 10.1093/rheumatology/kez275.

  • Jamaly S, Carlsson L, Peltonen M, Jacobson P, Karason K. Surgical obesity treatment and the risk of heart failure. Eur Heart J. 2019 Jul 1;40(26):2131-2138. doi: 10.1093/eurheartj/ehz295.

  • Zentenius E, Andersson-Assarsson JC, Carlsson LMS, Svensson PA, Larsson I. Self-Reported Weight-Loss Methods and Weight Change: Ten-Year Analysis in the Swedish Obese Subjects Study Control Group. Obesity (Silver Spring). 2018 Jul;26(7):1137-1143. doi: 10.1002/oby.22200. Epub 2018 Jun 6.

  • Maglio C, Peltonen M, Rudin A, Carlsson LMS. Bariatric Surgery and the Incidence of Psoriasis and Psoriatic Arthritis in the Swedish Obese Subjects Study. Obesity (Silver Spring). 2017 Dec;25(12):2068-2073. doi: 10.1002/oby.21955.

  • Manousou S, Carlsson LMS, Eggertsen R, Hulthen L, Jacobson P, Landin-Wilhelmsen K, Trimpou P, Svensson PA, Nystrom HF. Iodine Status After Bariatric Surgery-a Prospective 10-Year Report from the Swedish Obese Subjects (SOS) Study. Obes Surg. 2018 Feb;28(2):349-357. doi: 10.1007/s11695-017-2833-0.

  • Kanerva N, Larsson I, Peltonen M, Lindroos AK, Carlsson LM. Changes in total energy intake and macronutrient composition after bariatric surgery predict long-term weight outcome: findings from the Swedish Obese Subjects (SOS) study. Am J Clin Nutr. 2017 Jul;106(1):136-145. doi: 10.3945/ajcn.116.149112. Epub 2017 May 17.

  • Anveden A, Taube M, Peltonen M, Jacobson P, Andersson-Assarsson JC, Sjoholm K, Svensson PA, Carlsson LMS. Long-term incidence of female-specific cancer after bariatric surgery or usual care in the Swedish Obese Subjects Study. Gynecol Oncol. 2017 May;145(2):224-229. doi: 10.1016/j.ygyno.2017.02.036. Epub 2017 Mar 1.

  • Carlsson LMS, Sjoholm K, Karlsson C, Jacobson P, Andersson-Assarsson JC, Svensson PA, Larsson I, Hjorth S, Neovius M, Taube M, Carlsson B, Peltonen M. Long-term incidence of microvascular disease after bariatric surgery or usual care in patients with obesity, stratified by baseline glycaemic status: a post-hoc analysis of participants from the Swedish Obese Subjects study. Lancet Diabetes Endocrinol. 2017 Apr;5(4):271-279. doi: 10.1016/S2213-8587(17)30061-X. Epub 2017 Feb 23.

  • Maglio C, Peltonen M, Neovius M, Jacobson P, Jacobsson L, Rudin A, Carlsson LM. Effects of bariatric surgery on gout incidence in the Swedish Obese Subjects study: a non-randomised, prospective, controlled intervention trial. Ann Rheum Dis. 2017 Apr;76(4):688-693. doi: 10.1136/annrheumdis-2016-209958. Epub 2016 Oct 8.

  • Keating C, Neovius M, Sjoholm K, Peltonen M, Narbro K, Eriksson JK, Sjostrom L, Carlsson LM. Health-care costs over 15 years after bariatric surgery for patients with different baseline glucose status: results from the Swedish Obese Subjects study. Lancet Diabetes Endocrinol. 2015 Nov;3(11):855-65. doi: 10.1016/S2213-8587(15)00290-9. Epub 2015 Sep 17.

  • Sjoholm K, Pajunen P, Jacobson P, Karason K, Sjostrom CD, Torgerson J, Carlsson LM, Sjostrom L, Peltonen M. Incidence and remission of type 2 diabetes in relation to degree of obesity at baseline and 2 year weight change: the Swedish Obese Subjects (SOS) study. Diabetologia. 2015 Jul;58(7):1448-53. doi: 10.1007/s00125-015-3591-y. Epub 2015 Apr 30.

  • Konttinen H, Peltonen M, Sjostrom L, Carlsson L, Karlsson J. Psychological aspects of eating behavior as predictors of 10-y weight changes after surgical and conventional treatment of severe obesity: results from the Swedish Obese Subjects intervention study. Am J Clin Nutr. 2015 Jan;101(1):16-24. doi: 10.3945/ajcn.114.095182. Epub 2014 Nov 12.

  • Sjostrom L, Peltonen M, Jacobson P, Ahlin S, Andersson-Assarsson J, Anveden A, Bouchard C, Carlsson B, Karason K, Lonroth H, Naslund I, Sjostrom E, Taube M, Wedel H, Svensson PA, Sjoholm K, Carlsson LM. Association of bariatric surgery with long-term remission of type 2 diabetes and with microvascular and macrovascular complications. JAMA. 2014 Jun 11;311(22):2297-304. doi: 10.1001/jama.2014.5988.

  • Neovius M, Narbro K, Keating C, Peltonen M, Sjoholm K, Agren G, Sjostrom L, Carlsson L. Health care use during 20 years following bariatric surgery. JAMA. 2012 Sep 19;308(11):1132-41. doi: 10.1001/2012.jama.11792.

  • Carlsson LM, Peltonen M, Ahlin S, Anveden A, Bouchard C, Carlsson B, Jacobson P, Lonroth H, Maglio C, Naslund I, Pirazzi C, Romeo S, Sjoholm K, Sjostrom E, Wedel H, Svensson PA, Sjostrom L. Bariatric surgery and prevention of type 2 diabetes in Swedish obese subjects. N Engl J Med. 2012 Aug 23;367(8):695-704. doi: 10.1056/NEJMoa1112082.

  • Romeo S, Maglio C, Burza MA, Pirazzi C, Sjoholm K, Jacobson P, Svensson PA, Peltonen M, Sjostrom L, Carlsson LM. Cardiovascular events after bariatric surgery in obese subjects with type 2 diabetes. Diabetes Care. 2012 Dec;35(12):2613-7. doi: 10.2337/dc12-0193. Epub 2012 Aug 1.

  • Burza MA, Pirazzi C, Maglio C, Sjoholm K, Mancina RM, Svensson PA, Jacobson P, Adiels M, Baroni MG, Boren J, Ginanni Corradini S, Montalcini T, Sjostrom L, Carlsson LM, Romeo S. PNPLA3 I148M (rs738409) genetic variant is associated with hepatocellular carcinoma in obese individuals. Dig Liver Dis. 2012 Dec;44(12):1037-41. doi: 10.1016/j.dld.2012.05.006. Epub 2012 Jun 15.

MeSH Terms

Conditions

ObesityWeight Loss

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • Lena MS Carlsson, MD, PhD

    Göteborg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2011

First Posted

November 24, 2011

Study Start

January 1, 1987

Primary Completion

November 1, 2005

Study Completion

November 1, 2005

Last Updated

November 24, 2011

Record last verified: 2011-11

Locations