Severe Obesity: Bariatric Surgery vs. Life-Style-Intervention (WAS)
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.
Quality of Life
Procedure: gastric bypass
Behavioral: intensive life style intervention
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Severe Obesity: Bariatric Surgery vs. Life-Style-Intervention Wurzburg Adipositas Study - WAS|
- spiroergometry [ Time Frame: 12 months after surgery / life style intervention ] [ Designated as safety issue: No ]Improvement of V O2
- quality of life [ Time Frame: 12 months after bariatric surgery / life style intervention ] [ Designated as safety issue: No ]Improvement of quality of life, using SF 36
|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|
|gastric bypass||Procedure: gastric bypass|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01352403
|University hospital of Wuerzburg||Recruiting|
|Wuerzburg, Bavaria, Germany, 97080|
|Contact: Ann-Cathrin Koschker, MD 0049-931-20139716 firstname.lastname@example.org|
|Contact: Gwendolyn Bender, MD 0049-931-20139931 email@example.com|
|Principal Investigator: Bruno Allolio, Prof.|