Morbid Obesity: Effects of Conservative Treatments and Gastric Bypass Surgery
March 21, 2017 updated by: Norwegian University of Science and Technology
The purpose of this study is to evaluate the effects of conservative treatments of obesity with surgery (gastric bypass).
Study Overview
Detailed Description
The aim of this study is to evaluate 3 different treatments of obesity with gastric bypass.
Two groups will be treated in different clinics and 1 group will be treated at our outpatient clinic.
Sixty patients will participate in each group.
Behavioural changes and weight loss over 4-5 years will be followed.
We will also analyse changes in hormones, mental status, sexual behaviour, effect of training and quality of life.
Study Type
Interventional
Enrollment (Actual)
209
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Trondheim, Norway, 7011
- St. Olavs Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Body mass index (BMI) > 40 or BMI > 35 with complications
Exclusion Criteria:
- Unstable atherosclerotic disease
- Psychologically unstable
- Unable to participate in the training program
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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quality of life
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weight reduction
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Secondary Outcome Measures
Outcome Measure |
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reduction in obesity complications
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Baard Kulseng, PhD, MD, St. Olavs Hospital, Trondheim
- Principal Investigator: Ronald Mårvik, PhD, MD, St. Olavs Hospital, Trondheim
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Martins C, Strommen M, Stavne OA, Nossum R, Marvik R, Kulseng B. Bariatric surgery versus lifestyle interventions for morbid obesity--changes in body weight, risk factors and comorbidities at 1 year. Obes Surg. 2011 Jul;21(7):841-9. doi: 10.1007/s11695-010-0131-1.
- Ovrebo B, Strommen M, Kulseng B, Martins C. Bariatric surgery versus lifestyle interventions for severe obesity: 5-year changes in body weight, risk factors and comorbidities. Clin Obes. 2017 Jun;7(3):183-190. doi: 10.1111/cob.12190. Epub 2017 Mar 20.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2005
Primary Completion (Actual)
April 1, 2007
Study Completion (Actual)
August 1, 2007
Study Registration Dates
First Submitted
October 13, 2005
First Submitted That Met QC Criteria
October 14, 2005
First Posted (Estimate)
October 17, 2005
Study Record Updates
Last Update Posted (Actual)
March 24, 2017
Last Update Submitted That Met QC Criteria
March 21, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4.2005.33
- NSD12820 (Other Identifier: NSD)
- 05/3344TSP (Other Identifier: TSP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.