Effects of Bariatric Surgery in Swedish Obese Subjects (SOS)

November 23, 2011 updated by: Göteborg University
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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

4047

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

37 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Göteborg University

Collaborators

The Swedish Research Council

Investigators

  • Principal Investigator: Lena MS Carlsson, MD, PhD, Göteborg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1987

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

November 22, 2011

First Submitted That Met QC Criteria

November 23, 2011

First Posted (Estimate)

November 24, 2011

Study Record Updates

Last Update Posted (Estimate)

November 24, 2011

Last Update Submitted That Met QC Criteria

November 23, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOS-1987

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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