Effects of Bariatric Surgery in Swedish Obese Subjects - Full Text View

Purpose

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.

Condition	Intervention
Obesity	Procedure: Bariatric surgery Other: Usual care

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Effects of Bariatric Surgery in Swedish Obese Subjects

Resource links provided by NLM:

MedlinePlus related topics: Obesity Weight Loss Surgery

U.S. FDA Resources

Further study details as provided by Göteborg University:

Primary Outcome Measures:

Overall mortality [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
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.

Enrollment:	4047
Study Start Date:	January 1987
Study Completion Date:	November 2005
Primary Completion Date:	November 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Bariatric surgery Bariatric surgery	Procedure: Bariatric surgery Gastric banding, vertical banded gastroplasty, gastric bypass
Controls Usual care	Other: Usual care Non-surgical obesity treatment

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

Ages Eligible for Study:	37 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01479452

Locations

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

Sponsors and Collaborators

Göteborg University

The Swedish Research Council

Investigators

Principal Investigator:

Lena MS Carlsson, MD, PhD

Göteborg University

More Information

Publications:

Sjöström L, Lindroos AK, Peltonen M, Torgerson J, Bouchard C, Carlsson B, Dahlgren S, Larsson B, Narbro K, Sjöström 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.

Sjöström L, Narbro K, Sjöström 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, Lönroth H, Näslund I, Olbers T, Stenlöf 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.

Sjöström L, Gummesson A, Sjöström 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, Lönroth H, Näslund I, Olbers T, Stenlöf 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. Epub 2009 Jun 24.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Neovius M, Narbro K, Keating C, Peltonen M, Sjöholm K, Agren G, Sjöström L, Carlsson L. Health care use during 20 years following bariatric surgery. JAMA. 2012 Sep 19;308(11):1132-41.

Carlsson LM, Peltonen M, Ahlin S, Anveden Å, Bouchard C, Carlsson B, Jacobson P, Lönroth H, Maglio C, Näslund I, Pirazzi C, Romeo S, Sjöholm K, Sjöström E, Wedel H, Svensson PA, Sjöström L. Bariatric surgery and prevention of type 2 diabetes in Swedish obese subjects. N Engl J Med. 2012 Aug 23;367(8):695-704.

Romeo S, Maglio C, Burza MA, Pirazzi C, Sjöholm K, Jacobson P, Svensson PA, Peltonen M, Sjöström 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, Sjöholm K, Mancina RM, Svensson PA, Jacobson P, Adiels M, Baroni MG, Borén J, Ginanni Corradini S, Montalcini T, Sjöström 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.

Responsible Party:	Göteborg University
ClinicalTrials.gov Identifier:	NCT01479452 History of Changes
Other Study ID Numbers:	SOS-1987
Study First Received:	November 22, 2011
Last Updated:	November 23, 2011
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by Göteborg University:

obesity
bariatric surgery
weight loss

Additional relevant MeSH terms:

Obesity
Overnutrition
Nutrition Disorders

Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013

Effects of Bariatric Surgery in Swedish Obese Subjects (SOS)