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Effects of Bariatric Surgery in Swedish Obese Subjects (SOS)

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Bariatric surgery
Usual care
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, bariatric surgery, weight loss

Eligibility Criteria

37 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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).

Sites / Locations

  • SOS secretariat, Vita Straket 15, Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Bariatric surgery

Controls

Arm Description

Bariatric surgery

Usual care

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 22, 2011
Last Updated
November 23, 2011
Sponsor
Göteborg University
Collaborators
The Swedish Research Council
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1. Study Identification

Unique Protocol Identification Number
NCT01479452
Brief Title
Effects of Bariatric Surgery in Swedish Obese Subjects
Acronym
SOS
Official Title
Effects of Bariatric Surgery in Swedish Obese Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
January 1987 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
Collaborators
The Swedish Research Council

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, bariatric surgery, weight loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4047 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bariatric surgery
Arm Type
Other
Arm Description
Bariatric surgery
Arm Title
Controls
Arm Type
Other
Arm Description
Usual care
Intervention Type
Procedure
Intervention Name(s)
Bariatric surgery
Intervention Description
Gastric banding, vertical banded gastroplasty, gastric bypass
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Non-surgical obesity treatment
Primary Outcome Measure Information:
Title
Overall mortality
Description
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.
Time Frame
10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
37 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 37-60 years and BMI ≥34 kg/m2 in men and ≥38 kg/m2 in women. Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lena MS Carlsson, MD, PhD
Organizational Affiliation
Göteborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
SOS secretariat, Vita Straket 15, Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
41345
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
15616203
Citation
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.
Results Reference
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PubMed Identifier
17715408
Citation
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.
Results Reference
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PubMed Identifier
19556163
Citation
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.
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PubMed Identifier
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Citation
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.
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PubMed Identifier
34217404
Citation
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.
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PubMed Identifier
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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.
Results Reference
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PubMed Identifier
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Citation
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.
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PubMed Identifier
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Citation
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.
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PubMed Identifier
32931306
Citation
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.
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PubMed Identifier
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Citation
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.
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PubMed Identifier
32667228
Citation
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.
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PubMed Identifier
32128923
Citation
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.
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PubMed Identifier
31974103
Citation
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.
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PubMed Identifier
31664428
Citation
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.
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PubMed Identifier
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Citation
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.
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PubMed Identifier
31089682
Citation
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.
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PubMed Identifier
29873894
Citation
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.
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PubMed Identifier
29178583
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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.
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PubMed Identifier
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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.
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PubMed Identifier
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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.
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PubMed Identifier
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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.
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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.
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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.
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Effects of Bariatric Surgery in Swedish Obese Subjects

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