Clinical trial NCT01479452: Effects of Bariatric Surgery in Swedish Obese Subjects
Official title: Effects of Bariatric Surgery in Swedish Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
bariatric surgery
weight loss
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
First posted: 2011-11-24
Enrollment: 4047
Sex: ALL
Minimum age (years): 37
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Overall mortality
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: SOS secretariat, Vita Straket 15, Sahlgrenska University Hospital
Study officials:
affiliation: Göteborg University
name: Lena MS Carlsson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
citation: 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.