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Effects of Different Surgical Methods to Treat Obesity (DEOSH)

Primary Purpose

Obesity, Type 2 Diabetes, Insulin Sensitivity

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Omentectomy
Gastric bypass operation
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Bariatric Surgery, Insulin Sensitivity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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:

-

Sites / Locations

  • Södertälje Hospital
  • Ersta Hospital
  • Karolinska University Hospital Huddinge
  • Danderyds Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Control

Omentectomy

Arm Description

Gastric bypass operation without omentectomy.

Gastric bypass operation in conjunction with removal of greater omentum

Outcomes

Primary Outcome Measures

Insulin Sensitivity at 2 Years
Insulin sensitivity measured by hyperinsulinemic euglycemic clamp

Secondary Outcome Measures

Body Composition at Two Years
Blood Pressure at 2 Years
Body Mass Index at 2 Years
Blood Lipids

Full Information

First Posted
January 30, 2013
Last Updated
September 28, 2014
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm, The Swedish Research Council
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1. Study Identification

Unique Protocol Identification Number
NCT01785134
Brief Title
Effects of Different Surgical Methods to Treat Obesity
Acronym
DEOSH
Official Title
Metabolic Effects of Different Surgical Methods to Treat Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Region Stockholm, The Swedish Research Council

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Type 2 Diabetes, Insulin Sensitivity
Keywords
Obesity, Bariatric Surgery, Insulin Sensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Gastric bypass operation without omentectomy.
Arm Title
Omentectomy
Arm Type
Active Comparator
Arm Description
Gastric bypass operation in conjunction with removal of greater omentum
Intervention Type
Procedure
Intervention Name(s)
Omentectomy
Intervention Type
Procedure
Intervention Name(s)
Gastric bypass operation
Primary Outcome Measure Information:
Title
Insulin Sensitivity at 2 Years
Description
Insulin sensitivity measured by hyperinsulinemic euglycemic clamp
Time Frame
2 years postoperative
Secondary Outcome Measure Information:
Title
Body Composition at Two Years
Time Frame
2 years postoperative
Title
Blood Pressure at 2 Years
Time Frame
2 years postoperative
Title
Body Mass Index at 2 Years
Time Frame
2 years postoperative
Title
Blood Lipids
Time Frame
2 years postoperative

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik Näslund, MD, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Arner, MD, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Johan Hoffstedt, MD, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Study Chair
Facility Information:
Facility Name
Södertälje Hospital
City
Södertälje
State/Province
Stockholm
ZIP/Postal Code
15286
Country
Sweden
Facility Name
Ersta Hospital
City
Stockholm
ZIP/Postal Code
11691
Country
Sweden
Facility Name
Karolinska University Hospital Huddinge
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
Facility Name
Danderyds Hospital
City
Stockholm
ZIP/Postal Code
18288
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
33560372
Citation
van der Kolk BW, Muniandy M, Kaminska D, Alvarez M, Ko A, Miao Z, Valsesia A, Langin D, Vaittinen M, Paakkonen M, Jokinen R, Kaye S, Heinonen S, Virtanen KA, Andersson DP, Mannisto V, Saris WH, Astrup A, Ryden M, Blaak EE, Pajukanta P, Pihlajamaki J, Pietilainen KH. Differential Mitochondrial Gene Expression in Adipose Tissue Following Weight Loss Induced by Diet or Bariatric Surgery. J Clin Endocrinol Metab. 2021 Apr 23;106(5):1312-1324. doi: 10.1210/clinem/dgab072.
Results Reference
derived
PubMed Identifier
24485000
Citation
Andersson DP, Thorell A, Lofgren P, Wiren M, Toft E, Qvisth V, Riserus U, Berglund L, Naslund E, Bringman S, Thorne A, Arner P, Hoffstedt J. Omentectomy in addition to gastric bypass surgery and influence on insulin sensitivity: a randomized double blind controlled trial. Clin Nutr. 2014 Dec;33(6):991-6. doi: 10.1016/j.clnu.2014.01.004. Epub 2014 Jan 12.
Results Reference
derived

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Effects of Different Surgical Methods to Treat Obesity

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