DEOSH: Effects of Different Surgical Methods to Treat Obesity

• Sponsor: Karolinska Institutet (Other)
• Overall Status: Completed
• CT.gov ID: NCT01785134
• Collaborator: Region Stockholm (Other), The Swedish Research Council (Other)
• Enrollment: 81
• Locations: 4
• Arms: 2
• Duration (Months): 67
• Patients Per Site: 20.3
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Type 2 Diabetes; Insulin Sensitivity	Procedure: Omentectomy; Procedure: Gastric bypass operation	N/A

Study Design

• Study Type: Interventional
• 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 1, 2006
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

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

Primary Outcome Measures

1. Insulin Sensitivity at 2 Years [2 years postoperative]

   Insulin sensitivity measured by hyperinsulinemic euglycemic clamp

Secondary Outcome Measures

1. Body Composition at Two Years [2 years postoperative]

2. Blood Pressure at 2 Years [2 years postoperative]

3. Body Mass Index at 2 Years [2 years postoperative]

4. Blood Lipids [2 years postoperative]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Södertälje Hospital	Södertälje	Stockholm	Sweden	15286
2	Ersta Hospital	Stockholm		Sweden	11691
3	Karolinska University Hospital Huddinge	Stockholm		Sweden	14186
4	Danderyds Hospital	Stockholm		Sweden	18288

Sponsors and Collaborators

• Karolinska Institutet
• Region Stockholm
• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Erik Näslund, Professor, MD, PhD, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT01785134
• Other Study ID Numbers: CT20110061; CT20110061
• First Posted: Feb 7, 2013
• Last Update Posted: Oct 2, 2014
• Last Verified: Sep 1, 2014

• Keywords provided by Erik Näslund, Professor, MD, PhD, Karolinska Institutet: Obesity; Bariatric Surgery; Insulin Sensitivity
• Additional relevant MeSH terms: Obesity; Insulin Resistance; Hypersensitivity

Study Results

Participant Flow

Arm/Group Title	Control	Omentectomy
Arm/Group Description	Gastric bypass operation without omentectomy. Gastric bypass operation	Gastric bypass operation in conjunction with removal of greater omentum Omentectomy Gastric bypass operation
Period Title: Overall Study
STARTED	41	40
COMPLETED	29	33
NOT COMPLETED	12	7

Baseline Characteristics

Arm/Group Title	Control	Omentectomy	Total
Arm/Group Description	Gastric bypass operation without omentectomy. Gastric bypass operation	Gastric bypass operation in conjunction with removal of greater omentum Omentectomy Gastric bypass operation	Total of all reporting groups
Overall Participants	41	40	81
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41 (9)	43 (9)	42 (9)
Sex: Female, Male (Count of Participants)
Female	41 100%	40 100%	81 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Sweden	41 100%	40 100%	81 100%

Outcome Measures

1. Primary Outcome

Title	Insulin Sensitivity at 2 Years
Description	Insulin sensitivity measured by hyperinsulinemic euglycemic clamp
Time Frame	2 years postoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Omentectomy
Arm/Group Description	Gastric bypass operation without omentectomy. Gastric bypass operation	Gastric bypass operation in conjunction with removal of greater omentum Omentectomy Gastric bypass operation
Measure Participants	29	33
Mean (Standard Deviation) [glucose/kg body weight/min]	6.7 (1.6)	6.6 (1.5)

2. Secondary Outcome

Title	Body Composition at Two Years
Time Frame	2 years postoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Omentectomy
Arm/Group Description	Gastric bypass operation without omentectomy. Gastric bypass operation	Gastric bypass operation in conjunction with removal of greater omentum Omentectomy Gastric bypass operation
Measure Participants	29	33
Mean (Standard Deviation) [% body fat]	36 (8)	38 (8)

3. Secondary Outcome

Title	Blood Pressure at 2 Years
Time Frame	2 years postoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Omentectomy
Arm/Group Description	Gastric bypass operation without omentectomy. Gastric bypass operation	Gastric bypass operation in conjunction with removal of greater omentum Omentectomy Gastric bypass operation
Measure Participants	29	33
Mean (Standard Deviation) [mm Hg systolic]	123 (16)	121 (23)

4. Secondary Outcome

Title	Body Mass Index at 2 Years
Time Frame	2 years postoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Omentectomy
Arm/Group Description	Gastric bypass operation without omentectomy. Gastric bypass operation	Gastric bypass operation in conjunction with removal of greater omentum Omentectomy Gastric bypass operation
Measure Participants	29	33
Mean (Standard Deviation) [Kg/meter squared]	28.6 (4.6)	28.9 (4.3)

5. Secondary Outcome

Title	Blood Lipids
Time Frame	2 years postoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Omentectomy
Arm/Group Description	Gastric bypass operation without omentectomy. Gastric bypass operation	Gastric bypass operation in conjunction with removal of greater omentum Omentectomy Gastric bypass operation
Measure Participants	29	33
Mean (Standard Deviation) [P-Cholesterol mmol/L]	4.0 (0.9)	4.2 (0.8)

Adverse Events

Arm/Group Title	Control		Omentectomy
Arm/Group Description	Gastric bypass operation without omentectomy. Gastric bypass operation		Gastric bypass operation in conjunction with removal of greater omentum Omentectomy Gastric bypass operation
All Cause Mortality
	Control		Omentectomy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Control		Omentectomy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/40 (0%)
Other (Not Including Serious) Adverse Events
	Control		Omentectomy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/40 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.