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The Effect of Lifestyle Intervention Versus Gastric Bypass on Various Comorbidities in Morbidly Obese Subjects

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ClinicalTrials.gov Identifier: NCT00273104
Recruitment Status : Completed
First Posted : January 9, 2006
Last Update Posted : April 19, 2018
Sponsor:
Collaborator:
South-Eastern Norway Regional Health Authority
Information provided by (Responsible Party):
Jøran Hjelmesæth, The Hospital of Vestfold

Brief Summary:
This follow up study (>1 year) aims to compare the effects of lifestyle intervention and gastric by pass surgery on various comorbidities associated with morbid obesity.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Diabetes Mellitus Hypertension Procedure: Bariatric surgery Behavioral: Intensive lifestyle intervention Not Applicable

Detailed Description:
Not addressed

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Lifestyle Intervention vs Gastric Bypass on Various Comorbidities
Study Start Date : December 2005
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2017

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U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Bariatric surgery
Bariatric surgery (gastric bypass) offered to patients after informed consent and shared decision. The surgical procedure was performed at Vestfold Hospital Trust by experienced bariatric surgeons.
Procedure: Bariatric surgery
Bariatric surgery as a part of public health service offered treatment seeking morbidly obese patients.
Active Comparator: Intensive lifestyle intervention
Intensive lifestyle intervention (1-year endurance) at a rehabilitation centre. The intervention consisted of motivation for behaviour change including calorie restriction and increased physical activity.
Behavioral: Intensive lifestyle intervention
Intensive lifestyle intervention as a part of public health service offered treatment seeking morbidly obese patients.



Primary Outcome Measures :
  1. Improvement of co-morbidities [ Time Frame: 1-year after treatment start ]
    1-year comparative nonrandomized controlled trial


Secondary Outcome Measures :
  1. Safety issues [ Time Frame: 1-year ]
    Surgical complications and serious adverse events in both groups as published



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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:

  • Morbidly obese patients

Exclusion Criteria:


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): NCT00273104


Locations
Norway
Hospital in Vestfold
Tonsberg, Norway, 3117
Sponsors and Collaborators
The Hospital of Vestfold
South-Eastern Norway Regional Health Authority
Investigators
Principal Investigator: Jøran Hjelmesæth, MD PhD Hospital of Vestfold

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jøran Hjelmesæth, Head of Morbid Obesity Centre, The Hospital of Vestfold
ClinicalTrials.gov Identifier: NCT00273104     History of Changes
Other Study ID Numbers: S-05175
First Posted: January 9, 2006    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Diabetes Mellitus
Sleep Apnea, Obstructive
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases