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Morbid Obesity: Effects of Conservative Treatments and Gastric Bypass Surgery

This study has been completed.
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by:
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00239850
First received: October 13, 2005
Last updated: December 3, 2009
Last verified: December 2009
History of Changes
  Purpose

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


Condition Intervention
Morbid Obesity
 Behavioral: lifestyle changes

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Morbid Obesity: Effects of Conservative Treatments and Gastric Bypass Surgery

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • weight reduction
  • quality of life

Secondary Outcome Measures:
  • reduction in obesity complications

Estimated Enrollment: 240
Study Start Date: August 2005
Study Completion Date: August 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00239850

Locations
Norway
St. Olavs Hospital
Trondheim, Norway, 7011
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
Principal Investigator: Baard Kulseng, PhD, MD St. Olavs Hospital, Trondheim
Principal Investigator: Ronald Mårvik, PhD, MD St. Olavs Hospital, Trondheim
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00239850     History of Changes
Other Study ID Numbers: 4.2005.33, NSD 12820, 05/3344TSP
Study First Received: October 13, 2005
Last Updated: December 3, 2009
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:
obesity
lifestyle
treatment
Complications
 endocrine changes
Lipids
C18.654.726.500.495

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013