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Effects of Different Surgical Methods to Treat Obesity (DEOSH)

This study has been completed.
Sponsor:
Collaborators:
Stockholm County Council, Sweden
The Swedish Research Council
Information provided by (Responsible Party):
Erik Näslund, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01785134
First received: January 30, 2013
Last updated: September 28, 2014
Last verified: September 2014

January 30, 2013
September 28, 2014
May 2006
December 2011   (final data collection date for primary outcome measure)
Insulin Sensitivity at 2 Years [ Time Frame: 2 years postoperative ] [ Designated as safety issue: No ]
Insulin sensitivity measured by hyperinsulinemic euglycemic clamp
Change in insulin sensitivity [ Time Frame: Baseline and 2 years postoperative ] [ Designated as safety issue: No ]
Insulin sensitivity measured by hyperinsulinemic euglycemic clamp
Complete list of historical versions of study NCT01785134 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Change in body composition [ Time Frame: Baseline and 2 years postoperative ] [ Designated as safety issue: No ]
  • Change in blood pressure [ Time Frame: Baseline and 2 years postoperative ] [ Designated as safety issue: No ]
  • Change in weight and BMI [ Time Frame: Baseline and 2 years postoperative ] [ Designated as safety issue: No ]
  • Change in blood lipids [ Time Frame: Baseline and 2 years postoperative ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effects of Different Surgical Methods to Treat Obesity
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Obesity
  • Type 2 Diabetes
  • Insulin Sensitivity
  • Procedure: Omentectomy
  • Procedure: Gastric bypass operation
  • Sham Comparator: Control
    Gastric bypass operation without omentectomy.
    Intervention: Procedure: Gastric bypass operation
  • Active Comparator: Omentectomy
    Gastric bypass operation in conjunction with removal of greater omentum
    Interventions:
    • Procedure: Omentectomy
    • Procedure: Gastric bypass operation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
81
December 2011
December 2011   (final data collection date for primary outcome measure)

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:

-

Female
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01785134
CT20110061, CT20110061
No
Erik Näslund, Karolinska Institutet
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
Karolinska Institutet
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP