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Severe Obesity: Bariatric Surgery vs. Life-Style-Intervention (WAS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2008 by University of Wuerzburg.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01352403
First Posted: May 11, 2011
Last Update Posted: May 11, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Wuerzburg
  Purpose
The purpose of this study is to investigate the effects of gastric bypass in comparison to a intensive life style intervention on cardiac function and quality of life in patients with morbid obesity.

Condition Intervention
Obesity Cardiac Function Quality of Life Procedure: gastric bypass Behavioral: intensive life style intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Severe Obesity: Bariatric Surgery vs. Life-Style-Intervention Wurzburg Adipositas Study - WAS

Resource links provided by NLM:


Further study details as provided by University of Wuerzburg:

Primary Outcome Measures:
  • spiroergometry [ Time Frame: 12 months after surgery / life style intervention ]
    Improvement of V O2


Secondary Outcome Measures:
  • quality of life [ Time Frame: 12 months after bariatric surgery / life style intervention ]
    Improvement of quality of life, using SF 36


Estimated Enrollment: 60
Study Start Date: May 2011
Estimated Study Completion Date: June 2016
Arms Assigned Interventions
intensive life style intrvention
intensive life style intervention over 18 months including movement, psychological meetings and change in food intake
Behavioral: intensive life style intervention
gastric bypass Procedure: gastric bypass

Detailed Description:

Obesity ia associated with an elevated risk for cardiovascular diseases especially heart failure, atrial fibrillation and death from cardiovascular causes. Obese patients commonly have left ventricular hypertrophy and left atrial enlargement.

Conservative weight loss therapy is not effective in most patients with morbid obesity.Bariatric surgery is the only way to decrease weight effectively and permanently. Only few data are published concerning cardiac effects of bariatric surgery.

We randomize patients with morbid obesity for either gastric bypass or intensive life style intervention over 18 months and investigate the effects on cardiac function, weight and quality of life.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI > 40 without concomitant diseases, > 35 with concomitant diseases

Exclusion Criteria:

  • no gastric bypass possible, no spiroergometry possible, weight > 200 kg
  Contacts and Locations
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): NCT01352403


Locations
Germany
University hospital of Wuerzburg Recruiting
Wuerzburg, Bavaria, Germany, 97080
Contact: Ann-Cathrin Koschker, MD    0049-931-20139716    koschker_a@medizin.uni-wuerzburg.de   
Contact: Gwendolyn Bender, MD    0049-931-20139931    bender_g@medizin.uni-wuerzburg.de   
Principal Investigator: Bruno Allolio, Prof.         
Sponsors and Collaborators
University of Wuerzburg
  More Information

Responsible Party: Prof. Dr. Bruno Allolio, University hospital of Wuerzburg
ClinicalTrials.gov Identifier: NCT01352403     History of Changes
Other Study ID Numbers: 2008-005054-20
First Submitted: May 10, 2011
First Posted: May 11, 2011
Last Update Posted: May 11, 2011
Last Verified: December 2008

Keywords provided by University of Wuerzburg:
obesity
bariatric surgery
gastric bypass
life style intervention
cardiac function

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