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Morbid Obesity: Effects of Conservative Treatments and Gastric Bypass Surgery

Primary Purpose

Morbid Obesity

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
lifestyle changes
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring obesity, lifestyle, treatment, Complications, endocrine changes, Lipids, C18.654.726.500.495

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Olavs Hospital

Outcomes

Primary Outcome Measures

weight reduction
quality of life

Secondary Outcome Measures

reduction in obesity complications

Full Information

First Posted
October 13, 2005
Last Updated
March 21, 2017
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00239850
Brief Title
Morbid Obesity: Effects of Conservative Treatments and Gastric Bypass Surgery
Official Title
Morbid Obesity: Effects of Conservative Treatments and Gastric Bypass Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
August 2005 (Actual)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effects of conservative treatments of obesity with surgery (gastric bypass).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
obesity, lifestyle, treatment, Complications, endocrine changes, Lipids, C18.654.726.500.495

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
209 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
lifestyle changes
Primary Outcome Measure Information:
Title
weight reduction
Title
quality of life
Secondary Outcome Measure Information:
Title
reduction in obesity complications

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baard Kulseng, PhD, MD
Organizational Affiliation
St. Olavs Hospital, Trondheim
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ronald Mårvik, PhD, MD
Organizational Affiliation
St. Olavs Hospital, Trondheim
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Olavs Hospital
City
Trondheim
ZIP/Postal Code
7011
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
20379796
Citation
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.
Results Reference
result
PubMed Identifier
28320081
Citation
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.
Results Reference
result

Learn more about this trial

Morbid Obesity: Effects of Conservative Treatments and Gastric Bypass Surgery

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