Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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
  Purpose
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
Obesity
Type 2 Diabetes
Insulin Sensitivity
Procedure: Omentectomy
Procedure: Gastric bypass operation

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

Further study details as provided by Karolinska Institutet:

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


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

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01785134

Locations
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
Stockholm County Council, Sweden
The Swedish Research Council
Investigators
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Erik Näslund, Professor, MD, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01785134     History of Changes
Other Study ID Numbers: CT20110061
CT20110061 ( Registry Identifier: Karolinska Clinical Trial Registration )
Study First Received: January 30, 2013
Results First Received: September 19, 2014
Last Updated: September 28, 2014

Keywords provided by Karolinska Institutet:
Obesity
Bariatric Surgery
Insulin Sensitivity

Additional relevant MeSH terms:
Obesity
Hypersensitivity
Insulin Resistance
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 27, 2017