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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00273104
Other study ID # S-05175
Secondary ID
Status Completed
Phase N/A
First received January 5, 2006
Last updated April 18, 2018
Start date December 2005
Est. completion date December 2017

Study information

Verified date April 2018
Source The Hospital of Vestfold
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This follow up study (>1 year) aims to compare the effects of lifestyle intervention and gastric by pass surgery on various comorbidities associated with morbid obesity.


Description:

Not addressed


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date December 2017
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Morbidly obese patients

Exclusion Criteria:

Study Design


Intervention

Procedure:
Bariatric surgery
Bariatric surgery as a part of public health service offered treatment seeking morbidly obese patients.
Behavioral:
Intensive lifestyle intervention
Intensive lifestyle intervention as a part of public health service offered treatment seeking morbidly obese patients.

Locations

Country Name City State
Norway Hospital in Vestfold Tonsberg

Sponsors (2)

Lead Sponsor Collaborator
The Hospital of Vestfold South-Eastern Norway Regional Health Authority

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improvement of co-morbidities 1-year comparative nonrandomized controlled trial 1-year after treatment start
Secondary Safety issues Surgical complications and serious adverse events in both groups as published 1-year
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