Severe Obesity: Bariatric Surgery vs. Life-Style-Intervention (WAS)
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|ClinicalTrials.gov Identifier: NCT01352403|
Recruitment Status : Unknown
Verified December 2008 by University of Wuerzburg.
Recruitment status was: Recruiting
First Posted : May 11, 2011
Last Update Posted : May 11, 2011
|Condition or disease||Intervention/treatment||Phase|
|Obesity Cardiac Function Quality of Life||Procedure: gastric bypass Behavioral: intensive life style intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Severe Obesity: Bariatric Surgery vs. Life-Style-Intervention Wurzburg Adipositas Study - WAS|
|Study Start Date :||May 2011|
|Estimated Study Completion Date :||June 2016|
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
Procedure: gastric bypass
- spiroergometry [ Time Frame: 12 months after surgery / life style intervention ]Improvement of V O2
- quality of life [ Time Frame: 12 months after bariatric surgery / life style intervention ]Improvement of quality of life, using SF 36
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
|University hospital of Wuerzburg||Recruiting|
|Wuerzburg, Bavaria, Germany, 97080|
|Contact: Ann-Cathrin Koschker, MD 0049-931-20139716 email@example.com|
|Contact: Gwendolyn Bender, MD 0049-931-20139931 firstname.lastname@example.org|
|Principal Investigator: Bruno Allolio, Prof.|