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Completed

NCT Number: NCT01479452

Effects of Bariatric Surgery in Swedish Obese Subjects

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

37 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SOS secretariat, Vita Straket 15, Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

bariatric surgery

Procedure

Gastric banding, vertical banded gastroplasty, gastric bypass

Usual Care

Other

Non-surgical obesity treatment

Primary outcomes

  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.

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Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • The Swedish Research Council

Registry information

Acronym: SOS

Important dates

Study start
1987
Primary completion
2005
Study completion
2005
First posted
Nov 24, 2011
Registry last updated
Nov 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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