Effects of Different Surgical Methods to Treat Obesity (DEOSH)

September 28, 2014 updated by: Erik Näslund, Karolinska Institutet

Metabolic Effects of Different Surgical Methods to Treat Obesity

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

81

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
      • Stockholm, Sweden, 14186
        • Karolinska University Hospital Huddinge
      • Stockholm, Sweden, 11691
        • Ersta Hospital
      • Stockholm, Sweden, 18288
        • Danderyds Hospital
    • Stockholm
      • Södertälje, Stockholm, Sweden, 15286
        • Södertälje 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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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:

-

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: Gastric bypass operation
Procedure: Omentectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin Sensitivity at 2 Years
Time Frame: 2 years postoperative
Insulin sensitivity measured by hyperinsulinemic euglycemic clamp
2 years postoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
Body Composition at Two Years
Time Frame: 2 years postoperative
2 years postoperative
Blood Pressure at 2 Years
Time Frame: 2 years postoperative
2 years postoperative
Body Mass Index at 2 Years
Time Frame: 2 years postoperative
2 years postoperative
Blood Lipids
Time Frame: 2 years postoperative
2 years postoperative

Collaborators and Investigators

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

Sponsor

Karolinska Institutet

Collaborators

The Swedish Research Council
Region Stockholm

Investigators

  • Principal Investigator: Erik Naslund, MD, PhD, Karolinska Institutet
  • Study Director: Peter Arner, MD, PhD, Karolinska Institutet
  • Study Chair: Johan Hoffstedt, MD, PhD, Karolinska Institutet

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

May 1, 2006

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

January 30, 2013

First Submitted That Met QC Criteria

February 4, 2013

First Posted (Estimate)

February 7, 2013

Study Record Updates

Last Update Posted (Estimate)

October 2, 2014

Last Update Submitted That Met QC Criteria

September 28, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT20110061 (Registry Identifier: Karolinska Clinical Trial Registration)

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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