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: February 4, 2013
Last verified: February 2013
  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
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:
  • Change in insulin sensitivity [ Time Frame: Baseline and 2 years postoperative ] [ Designated as safety issue: No ]
    Insulin sensitivity measured by hyperinsulinemic euglycemic clamp


Secondary Outcome Measures:
  • 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 ]

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
Genders 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
Karolinska University Hospital Huddinge
Stockholm, Sweden, 14186
Danderyds Hospital
Stockholm, Sweden, 18288
Ersta Hospital
Stockholm, Sweden, 11691
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

No publications provided

Responsible Party: Erik Näslund, Professor, MD, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01785134     History of Changes
Other Study ID Numbers: CT20110061, CT20110061
Study First Received: January 30, 2013
Last Updated: February 4, 2013
Health Authority: Sweden: Swedish Data Inspection Board
Sweden: The National Board of Health and Welfare

Keywords provided by Karolinska Institutet:
Obesity
Bariatric Surgery
Insulin Sensitivity

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Obesity
Insulin Resistance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hyperinsulinism

ClinicalTrials.gov processed this record on July 31, 2014