ObesitySOSNCT01479452

Effects of Bariatric Surgery in Swedish Obese Subjects

A study testing Bariatric surgery in people with Obesity, run by Göteborg University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 37 to 60 years
Conditions the study is for: Obesity
What is being tested?: Bariatric surgery
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4,047 participants
Where: 1 siteSweden
Study dates: Jan 1987to Nov 2005
Phase: Interventional
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 37 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

Exclusion criteria of both groups were: earlier operation for gastric or duodenal ulcer; earlier bariatric surgery
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).

Trial locations and contacts

1 site in 1 country.

Sweden1 site

SOS secretariat, Vita Straket 15, Sahlgrenska University Hospital
Gothenburg, 41345

Other trials in Sweden

About this study

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.

Read the detailed description

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: Obesity
Being tested: Bariatric surgery, Usual care
Keywords: obesity, bariatric surgery, weight loss
Medical subject headings: Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bariatric surgeryProcedure or surgery
Gastric banding, vertical banded gastroplasty, gastric bypass
Usual careOther
Non-surgical obesity treatment

Study groups in NCT01479452
Study group	Role	What they receive
Bariatric surgery	Other	Bariatric surgery Receives: Procedure: Bariatric surgery
Controls	Other	Usual care Receives: Other: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 1987Nov 2005

First posted24 Nov 2011 (estimated)
Study startJan 1987
Primary completionNov 2005
Study completionNov 2005

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (42)Papers the sponsor has linked to this study.
Other trials for ObesityStudies of the same condition, open and under way.
More trials run by Göteborg UniversityThe 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 4,047 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01479452
Sponsor's protocol ID: SOS-1987
Acronym: SOS
Status last verified: Nov 2011
First submitted: 22 Nov 2011
Last updated: 24 Nov 2011
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 15616203
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.
PubMed 17715408
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.
PubMed 19556163
Langegard E, Kristensson FM, Andersson-Assarsson JC, Peltonen M, Svensson PA, Jacobson P, Ahlin S, Sjoholm K, Carlsson LMS, Taube M. Association between FTO rs9939609 genotype and breast cancer risk after bariatric surgery in the Swedish Obese Subjects study. Sci Rep. 2026 May 6;16(1):14429. doi: 10.1038/s41598-026-51884-2.
PubMed 42091990
Brembeck P, Andersson-Assarsson JC, Peltonen M, Taube M, Sjoholm K, Ahlin S, Admeus L, Konttinen H, Larsson I, Engstrom M, Henning B, Carlsson LMS, Svensson PA. Association between bariatric surgery and long-term ability to perform household tasks in the Swedish Obese Subjects study: a controlled prospective cohort study. BMC Med. 2026 Apr 18;24(1):257. doi: 10.1186/s12916-026-04836-6.
PubMed 42001100
Arnetorp I, Peltonen M, Sjoholm K, Svensson PA, Jacobson P, Taube M, Carlsson LMS, Andersson-Assarsson JC, Ahlin S. Obstructive Sleep Apnea Following Bariatric Surgery: 20 Year Outcomes From the Swedish Obese Subjects Study. Obesity (Silver Spring). 2026 Apr;34(4):819-828. doi: 10.1002/oby.70154. Epub 2026 Feb 25.
PubMed 41738458
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.
PubMed 41490246
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.
PubMed 40353980
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.
PubMed 40166366
Carlsson LMS, Carlsson B, Jacobson P, Andersson-Assarsson JC, Karlsson C, Kristensson FM, Ahlin S, Naslund I, Karason K, Svensson PA, Taube M, Peltonen M, Sjoholm K. Association between delay in diabetes development and mortality in people with obesity: Up to 33 years follow-up of the prospective Swedish Obese Subjects study. Diabetes Obes Metab. 2025 Jan;27(1):238-246. doi: 10.1111/dom.16010. Epub 2024 Oct 21.
PubMed 39434432
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.
PubMed 38896851
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.
PubMed 38748431
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.
PubMed 37716360
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.
PubMed 36754250
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.
PubMed 34799430

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Bariatric Surgery in Swedish Obese Subjects
ClinicalTrials.gov ID: NCT01479452
Acronym / sponsor ID: SOS / SOS-1987
Conditions: Obesity
Keywords: obesity, bariatric surgery, weight loss
Study type: Interventional
Recruitment status: Completed
Enrolment: 4,047 participants (actual)
Lead sponsor: Göteborg UniversityUniversity, hospital or other
Collaborators: The Swedish Research Council
Study start: Jan 1987
Primary completion: Nov 2005 (actual)
Study completion: Nov 2005 (actual)
First posted: 24 Nov 2011 (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.

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Bariatric surgery	Other	Procedure: Bariatric surgeryBariatric surgery
Controls	Other	Other: Usual careUsual care

Who may qualify

Ages: 37 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (7 listed)

Exclusion criteria of both groups were: earlier operation for gastric or duodenal ulcer; earlier bariatric surgery
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bariatric surgeryGastric banding, vertical banded gastroplasty, gastric bypass	Procedure or surgery	Bariatric surgery
Usual careNon-surgical obesity treatment	Other	Controls

Primary outcome

Overall mortality
Time frame: 10 years
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.

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 Nov 2011.
Results publication: PubMed 15616203Sjostrom 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.
Results publication: PubMed 17715408Sjostrom 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.
Results publication: PubMed 19556163Sjostrom 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.
Derived from this study: PubMed 42091990Langegard E, Kristensson FM, Andersson-Assarsson JC, Peltonen M, Svensson PA, Jacobson P, Ahlin S, Sjoholm K, Carlsson LMS, Taube M. Association between FTO rs9939609 genotype and breast cancer risk after bariatric surgery in the Swedish Obese Subjects study. Sci Rep. 2026 May 6;16(1):14429. doi: 10.1038/s41598-026-51884-2.
Derived from this study: PubMed 42001100Brembeck P, Andersson-Assarsson JC, Peltonen M, Taube M, Sjoholm K, Ahlin S, Admeus L, Konttinen H, Larsson I, Engstrom M, Henning B, Carlsson LMS, Svensson PA. Association between bariatric surgery and long-term ability to perform household tasks in the Swedish Obese Subjects study: a controlled prospective cohort study. BMC Med. 2026 Apr 18;24(1):257. doi: 10.1186/s12916-026-04836-6.
Derived from this study: PubMed 41738458Arnetorp I, Peltonen M, Sjoholm K, Svensson PA, Jacobson P, Taube M, Carlsson LMS, Andersson-Assarsson JC, Ahlin S. Obstructive Sleep Apnea Following Bariatric Surgery: 20 Year Outcomes From the Swedish Obese Subjects Study. Obesity (Silver Spring). 2026 Apr;34(4):819-828. doi: 10.1002/oby.70154. Epub 2026 Feb 25.
Derived from this study: PubMed 41490246Sjoholm 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.
Derived from this study: PubMed 40353980Carlsson 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.
Derived from this study: PubMed 40166366Carlsson 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.
Derived from this study: PubMed 39434432Carlsson LMS, Carlsson B, Jacobson P, Andersson-Assarsson JC, Karlsson C, Kristensson FM, Ahlin S, Naslund I, Karason K, Svensson PA, Taube M, Peltonen M, Sjoholm K. Association between delay in diabetes development and mortality in people with obesity: Up to 33 years follow-up of the prospective Swedish Obese Subjects study. Diabetes Obes Metab. 2025 Jan;27(1):238-246. doi: 10.1111/dom.16010. Epub 2024 Oct 21.
Derived from this study: PubMed 38896851Carlsson 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.
Derived from this study: PubMed 38748431Kristensson 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.

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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.

Lena MS Carlsson, MD, PhD principal investigator

Göteborg University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Bariatric surgery in people with Obesity, run by Göteborg University at 1 site in Sweden.

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 1 inclusion and 7 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 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. 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?

Overall mortality (time frame: 10 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 NCT01479452, which also lists 42 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 Nov 2011.