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Trial record 1 of 1 for:    DEOSH
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Effects of Different Surgical Methods to Treat Obesity (DEOSH)

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ClinicalTrials.gov Identifier: NCT01785134
Recruitment Status : Completed
First Posted : February 7, 2013
Results First Posted : October 2, 2014
Last Update Posted : October 2, 2014
Sponsor:
Collaborators:
Region Stockholm
The Swedish Research Council
Information provided by (Responsible Party):
Erik Näslund, Karolinska Institutet

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Obesity Type 2 Diabetes Insulin Sensitivity Procedure: Omentectomy Procedure: Gastric bypass operation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Metabolic Effects of Different Surgical Methods to Treat Obesity
Study Start Date : May 2006
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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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: Omentectomy
Procedure: Gastric bypass operation


Outcome Measures
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Primary Outcome Measures :
  1. Insulin Sensitivity at 2 Years [ Time Frame: 2 years postoperative ]
    Insulin sensitivity measured by hyperinsulinemic euglycemic clamp


Secondary Outcome Measures :
  1. Body Composition at Two Years [ Time Frame: 2 years postoperative ]
  2. Blood Pressure at 2 Years [ Time Frame: 2 years postoperative ]
  3. Body Mass Index at 2 Years [ Time Frame: 2 years postoperative ]
  4. Blood Lipids [ Time Frame: 2 years postoperative ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01785134


Locations
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Sweden
Södertälje Hospital
Södertälje, Stockholm, Sweden, 15286
Ersta Hospital
Stockholm, Sweden, 11691
Karolinska University Hospital Huddinge
Stockholm, Sweden, 14186
Danderyds Hospital
Stockholm, Sweden, 18288
Sponsors and Collaborators
Karolinska Institutet
Region Stockholm
The Swedish Research Council
Investigators
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Erik Näslund, Professor, MD, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01785134    
Other Study ID Numbers: CT20110061
CT20110061 ( Registry Identifier: Karolinska Clinical Trial Registration )
First Posted: February 7, 2013    Key Record Dates
Results First Posted: October 2, 2014
Last Update Posted: October 2, 2014
Last Verified: September 2014
Keywords provided by Erik Näslund, Karolinska Institutet:
Obesity
Bariatric Surgery
Insulin Sensitivity
Additional relevant MeSH terms:
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Obesity
Insulin Resistance
Hypersensitivity
Overnutrition
Nutrition Disorders
Overweight
 Body Weight
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases