Effects of Bariatric Surgery in Swedish Obese Subjects (SOS)

This study has been completed.
Sponsor:
Collaborator:
The Swedish Research Council
Information provided by (Responsible Party):
Göteborg University
ClinicalTrials.gov Identifier:
NCT01479452
First received: November 22, 2011
Last updated: November 23, 2011
Last verified: November 2011
  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:


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
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, see Learn About Clinical Studies.

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

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 August 26, 2014