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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 (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00239850
First received: October 13, 2005
Last updated: March 21, 2017
Last verified: March 2017
  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
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Morbid Obesity: Effects of Conservative Treatments and Gastric Bypass Surgery

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

Enrollment: 209
Actual 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   (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
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 )
Study First Received: October 13, 2005
Last Updated: March 21, 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

ClinicalTrials.gov processed this record on June 27, 2017