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Trial record 1 of 1 for:    NCT01479452
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Effects of Bariatric Surgery in Swedish Obese Subjects (SOS)

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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

Tracking Information
First Submitted Date  ICMJE November 22, 2011
First Posted Date  ICMJE November 24, 2011
Last Update Posted Date November 24, 2011
Study Start Date  ICMJE January 1987
Actual Primary Completion Date November 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Bariatric Surgery in Swedish Obese Subjects
Official Title  ICMJE Effects of Bariatric Surgery in Swedish Obese Subjects
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • Procedure: Bariatric surgery
    Gastric banding, vertical banded gastroplasty, gastric bypass
  • Other: Usual care
    Non-surgical obesity treatment
Study Arms  ICMJE
  • Bariatric surgery
    Bariatric surgery
    Intervention: Procedure: Bariatric surgery
  • Controls
    Usual care
    Intervention: Other: Usual care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 23, 2011)
4047
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2005
Actual Primary Completion Date November 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 37 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01479452
Other Study ID Numbers  ICMJE SOS-1987
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Göteborg University
Study Sponsor  ICMJE Göteborg University
Collaborators  ICMJE The Swedish Research Council
Investigators  ICMJE
Principal Investigator: Lena MS Carlsson, MD, PhD Göteborg University
PRS Account Göteborg University
Verification Date November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP