Effects of Different Surgical Methods to Treat Obesity

Obesity Clinical Trial

— DEOSH  

Official title:

Metabolic Effects of Different Surgical Methods to Treat Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01785134
• Other study ID #: CT20110061
• Secondary ID: CT20110061
• Status: Completed
• Phase: N/A
• First received: January 30, 2013
• Last updated: September 28, 2014
• Start date: May 2006
• Est. completion date: December 2011

Study information

• Verified date: September 2014
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Swedish Data Inspection BoardSweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insulin Resistance
• Insulin Sensitivity
• Obesity
• Type 2 Diabetes

Intervention

Procedure:
• Omentectomy

• Gastric bypass operation

Locations

Country	Name	City	State
Sweden	Södertälje Hospital	Södertälje	Stockholm
Sweden	Danderyds Hospital	Stockholm
Sweden	Ersta Hospital	Stockholm
Sweden	Karolinska University Hospital Huddinge	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm County Council, Sweden, The Swedish Research Council

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin Sensitivity at 2 Years	Insulin sensitivity measured by hyperinsulinemic euglycemic clamp	2 years postoperative	No
Secondary	Body Composition at Two Years		2 years postoperative	No
Secondary	Blood Pressure at 2 Years		2 years postoperative	No
Secondary	Body Mass Index at 2 Years		2 years postoperative	No
Secondary	Blood Lipids		2 years postoperative	No