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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2008 by University of Wuerzburg
Sponsor:
Information provided by:
University of Wuerzburg
ClinicalTrials.gov Identifier:
NCT01352403
First received: May 10, 2011
Last updated: NA
Last verified: December 2008
History: No changes posted
  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
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

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 ] [ Designated as safety issue: No ]
    Improvement of V O2


Secondary Outcome Measures:
  • 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


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Prof. Dr. Bruno Allolio, University hospital of Wuerzburg
ClinicalTrials.gov Identifier: NCT01352403     History of Changes
Other Study ID Numbers: 2008-005054-20
Study First Received: May 10, 2011
Last Updated: May 10, 2011
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on November 25, 2014