Effects of Bariatric Surgery in Swedish Obese Subjects

Obesity Clinical Trial

— SOS  

Official title:

Effects of Bariatric Surgery in Swedish Obese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01479452
• Other study ID #: SOS-1987
• Status: Completed
• Phase: N/A
• First received: November 22, 2011
• Last updated: November 23, 2011
• Start date: January 1987
• Est. completion date: November 2005

Study information

• Verified date: November 2011
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4047
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 37 Years to 60 Years

Eligibility

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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Procedure:
• Bariatric surgery
Gastric banding, vertical banded gastroplasty, gastric bypass

Other:
• Usual care
Non-surgical obesity treatment

Locations

Country	Name	City	State
Sweden	SOS secretariat, Vita Straket 15, Sahlgrenska University Hospital	Gothenburg

Sponsors (2)

Lead Sponsor	Collaborator
Göteborg University	The Swedish Research Council

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

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 O — View Citation

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 — View Citation

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, Car — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 years	Yes