We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Bariatric Surgery in Swedish Obese Subjects (SOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01479452
Recruitment Status : Completed
First Posted : November 24, 2011
Last Update Posted : November 24, 2011
Sponsor:
Collaborator:
The Swedish Research Council
Information provided by (Responsible Party):
Göteborg University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Obesity Procedure: Bariatric surgery Other: Usual care Not Applicable

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4047 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Bariatric Surgery in Swedish Obese Subjects
Study Start Date : January 1987
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Bariatric surgery
Bariatric surgery
 Procedure: Bariatric surgery
Gastric banding, vertical banded gastroplasty, gastric bypass
Controls
Usual care
 Other: Usual care
Non-surgical obesity treatment


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   37 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01479452


Locations
Layout table for location information
Sweden
SOS secretariat, Vita Straket 15, Sahlgrenska University Hospital
Gothenburg, Sweden, 41345
Sponsors and Collaborators
Göteborg University
The Swedish Research Council
Investigators
Layout table for investigator information
Principal Investigator: Lena MS Carlsson, MD, PhD Göteborg University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

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

Layout table for additonal information
Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT01479452    
Other Study ID Numbers: SOS-1987
First Posted: November 24, 2011    Key Record Dates
Last Update Posted: November 24, 2011
Last Verified: November 2011
Keywords provided by Göteborg University:
obesity
bariatric surgery
weight loss
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight