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

This study has been completed.

First Received: January 5, 2006 Last Updated: January 28, 2009 History of Changes

Sponsors and Collaborators:	The Hospital of Vestfold Health Region South-East
Information provided by:	The Hospital of Vestfold
ClinicalTrials.gov Identifier:	NCT00273104

Purpose

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	Intervention	Phase
Obstructive Sleep Apnea Diabetes Mellitus Hypertension	Procedure: Behavior	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Effect of Lifestyle Intervention vs Gastric Bypass on Various Comorbidities

Resource links provided by NLM:

MedlinePlus related topics: Diabetes High Blood Pressure Obesity Sleep Apnea

U.S. FDA Resources

Further study details as provided by The Hospital of Vestfold:

Primary Outcome Measures:

Improvement of co-morbidities

Estimated Enrollment:	180
Study Start Date:	December 2005
Estimated Study Completion Date:	December 2009

Detailed Description:

Not addressed

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Morbidly obese patients

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00273104

Locations

Norway
Hospital in Vestfold
Tonsberg, Norway, 3117

Sponsors and Collaborators

The Hospital of Vestfold

Health Region South-East

Investigators

Principal Investigator:

Jøran Hjelmesæth, MD PhD

Hospital of Vestfold

More Information

No publications provided

Responsible Party:	( Health Region South-East )
Study ID Numbers:	S-05175
Study First Received:	January 5, 2006
Last Updated:	January 28, 2009
ClinicalTrials.gov Identifier:	NCT00273104 History of Changes
Health Authority:	Norway: The National Committees for Research Ethics in Norway

Study placed in the following topic categories:

Obesity
Sleep Apnea Syndromes
Metabolic Diseases
Apnea
Sleep Apnea, Obstructive
Respiration Disorders
Diabetes Mellitus
Vascular Diseases
Dyssomnias

Endocrine System Diseases
Sleep Disorders
Sleep Disorders, Intrinsic
Respiratory Tract Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Hypertension

Additional relevant MeSH terms:

Sleep Apnea Syndromes
Metabolic Diseases
Apnea
Nervous System Diseases
Sleep Apnea, Obstructive
Respiration Disorders
Diabetes Mellitus
Vascular Diseases

Sleep Disorders
Dyssomnias
Endocrine System Diseases
Sleep Disorders, Intrinsic
Respiratory Tract Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Hypertension

ClinicalTrials.gov processed this record on September 01, 2009