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Effects of Different Surgical Methods to Treat Obesity (DEOSH)

This study has been completed.
Stockholm County Council, Sweden
The Swedish Research Council
Information provided by (Responsible Party):
Erik Näslund, Karolinska Institutet Identifier:
First received: January 30, 2013
Last updated: September 28, 2014
Last verified: September 2014

Obese patients have an increased risk for developing severe metabolic disorders. This risk can only partly be reduced by weight reduction. The investigators have in a pilot study investigated if removal of abdominal fat (visceral) in addition to weight loss has additional beneficial effects on the metabolic profile and weight loss. This study aims to further investigate if removal of abdominal fat (major omentum) leads to beneficial metabolic effects.

Condition Intervention
Type 2 Diabetes
Insulin Sensitivity
Procedure: Omentectomy
Procedure: Gastric bypass operation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Metabolic Effects of Different Surgical Methods to Treat Obesity

Resource links provided by NLM:

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Insulin Sensitivity at 2 Years [ Time Frame: 2 years postoperative ] [ Designated as safety issue: No ]
    Insulin sensitivity measured by hyperinsulinemic euglycemic clamp

Secondary Outcome Measures:
  • Body Composition at Two Years [ Time Frame: 2 years postoperative ] [ Designated as safety issue: No ]
  • Blood Pressure at 2 Years [ Time Frame: 2 years postoperative ] [ Designated as safety issue: No ]
  • Body Mass Index at 2 Years [ Time Frame: 2 years postoperative ] [ Designated as safety issue: No ]
  • Blood Lipids [ Time Frame: 2 years postoperative ] [ Designated as safety issue: No ]

Enrollment: 81
Study Start Date: May 2006
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Control
Gastric bypass operation without omentectomy.
Procedure: Gastric bypass operation
Active Comparator: Omentectomy
Gastric bypass operation in conjunction with removal of greater omentum
Procedure: Omentectomy Procedure: Gastric bypass operation


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Body mass index over 40 kg/m2

Body mass index over 35 kg/m2 with obesity associated co-morbidities such as type 2 diabetes and/or additional cardiovascular risk factors -

Exclusion Criteria:


  Contacts and Locations
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Please refer to this study by its identifier: NCT01785134

Södertälje Hospital
Södertälje, Stockholm, Sweden, 15286
Danderyds Hospital
Stockholm, Sweden, 18288
Ersta Hospital
Stockholm, Sweden, 11691
Karolinska University Hospital Huddinge
Stockholm, Sweden, 14186
Sponsors and Collaborators
Karolinska Institutet
Stockholm County Council, Sweden
The Swedish Research Council
Principal Investigator: Erik Näslund, MD, PhD Karolinska Institutet
Study Director: Peter Arner, MD, PhD Karolinska Institutet
Study Chair: Johan Hoffstedt, MD, PhD Karolinska Institutet
  More Information

No publications provided by Karolinska Institutet

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Erik Näslund, Professor, MD, PhD, Karolinska Institutet Identifier: NCT01785134     History of Changes
Other Study ID Numbers: CT20110061, CT20110061
Study First Received: January 30, 2013
Results First Received: September 19, 2014
Last Updated: September 28, 2014
Health Authority: Sweden: Swedish Data Inspection Board
Sweden: The National Board of Health and Welfare

Keywords provided by Karolinska Institutet:
Bariatric Surgery
Insulin Sensitivity processed this record on March 03, 2015