Effects of Bariatric Surgery in Swedish Obese Subjects

NCT ID: NCT01479452

Last Updated: 2011-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4047 participants

Study Classification

INTERVENTIONAL

Study Start Date

1987-01-31

Study Completion Date

2005-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The Swedish Obese Subjects (SOS) study is a prospective non-randomized controlled intervention study designed to examine the long-term effects of bariatric surgery compared to usual care in obese subjects.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

obesity bariatric surgery weight loss

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bariatric surgery

Bariatric surgery

Group Type OTHER

Bariatric surgery

Intervention Type PROCEDURE

Gastric banding, vertical banded gastroplasty, gastric bypass

Controls

Usual care

Group Type OTHER

Usual care

Intervention Type OTHER

Non-surgical obesity treatment

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bariatric surgery

Gastric banding, vertical banded gastroplasty, gastric bypass

Intervention Type PROCEDURE

Usual care

Non-surgical obesity treatment

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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).
Minimum Eligible Age

37 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Swedish Research Council

OTHER_GOV

Sponsor Role collaborator

Göteborg University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lena MS Carlsson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Göteborg University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

SOS secretariat, Vita Straket 15, Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 15616203 (View on PubMed)

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.

Reference Type RESULT
PMID: 17715408 (View on PubMed)

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.

Reference Type RESULT
PMID: 19556163 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40353980 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40166366 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38896851 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38748431 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37716360 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36754250 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34799430 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34217404 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33961331 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33764991 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33053284 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32931306 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32873586 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32667228 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32128923 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31974103 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31664428 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31321442 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31089682 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29873894 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29178583 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28766267 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28515062 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28259424 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28237791 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28076240 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26386667 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25924987 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25527746 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24915261 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22990272 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22913680 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22855732 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22704398 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SOS-1987

Identifier Type: -

Identifier Source: org_study_id