Effects of Different Surgical Methods to Treat Obesity

Not Applicable

Completed

• Conditions: Obesity; Type 2 Diabetes; Insulin Sensitivity
• Interventions: Procedure: Gastric bypass operation; Procedure: Omentectomy

• Registration Number: NCT01785134
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Study First Submitted: 2013-01-30
• Study First Submitted QC: 2013-02-04
• Study First Posted: 2013-02-07
• Status Verified: 2014-09
• Results First Submitted: 2014-09-19
• Results First Submitted QC: 2014-09-28
• Last Update Submitted: 2014-09-28
• Results First Posted: 2014-10-02
• Last Update Posted: 2014-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 81

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Gastric bypass operation	Gastric bypass operation without omentectomy.
Omentectomy	Gastric bypass operation	Gastric bypass operation in conjunction with removal of greater omentum
Omentectomy	Omentectomy	Gastric bypass operation in conjunction with removal of greater omentum

Primary Outcome Measures

Name	Time	Method
Insulin Sensitivity at 2 Years	2 years postoperative	Insulin sensitivity measured by hyperinsulinemic euglycemic clamp

Secondary Outcome Measures

Name	Time	Method
Body Composition at Two Years	2 years postoperative
Blood Pressure at 2 Years	2 years postoperative
Blood Lipids	2 years postoperative
Body Mass Index at 2 Years	2 years postoperative

Trial Locations

Locations (4)

Ersta Hospital; 🇸🇪 Stockholm, Sweden

Karolinska University Hospital Huddinge; 🇸🇪 Stockholm, Sweden

Södertälje Hospital; 🇸🇪 Södertälje, Stockholm, Sweden

Danderyds Hospital; 🇸🇪 Stockholm, Sweden