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Morbid Obesity: Effects of Conservative Treatments and Gastric Bypass Surgery

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ClinicalTrials.gov Identifier: NCT00239850
Recruitment Status : Completed
First Posted : October 17, 2005
Last Update Posted : March 24, 2017
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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

Condition or disease Intervention/treatment Phase
Morbid Obesity Behavioral: lifestyle changes Not Applicable

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  (Clinical Trial)
Actual Enrollment : 209 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Morbid Obesity: Effects of Conservative Treatments and Gastric Bypass Surgery
Actual Study Start Date : August 2005
Actual Primary Completion Date : April 2007
Actual Study Completion Date : August 2007



Primary Outcome Measures :
  1. weight reduction
  2. quality of life

Secondary Outcome Measures :
  1. reduction in obesity complications


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00239850     History of Changes
Other Study ID Numbers: 4.2005.33
NSD12820 ( Other Identifier: NSD )
05/3344TSP ( Other Identifier: TSP )
First Posted: October 17, 2005    Key Record Dates
Last Update Posted: March 24, 2017
Last Verified: March 2017

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

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