Obesity Clinical Trial - Severe Obesity: Bariatric Surgery vs.

Status Completed

Clinical Trial Summary

The purpose of this study is to investigate the effects of weight loss induced by gastric bypass surgery in comparison to a psychotherapy-enhanced lifestyle intervention on cardiopulmonary performance and quality of life in patients with morbid obesity.

Clinical Trial Description

Obesity is a rapidly emerging health problem and an established risk factor for cardiovascular diseases. Bariatric surgery profoundly reduces body weight and mitigates sequelae of obesity. Especially randomized trials comparing the effects of bariatric surgery to conservative treatment in concerns of cardiac function are still lacking. The randomized WAS trial compares the effects of Roux-en-Y gastric bypass (RYGB) versus psychotherapy-supported lifestyle modification in morbidly obese patients. The co-primary endpoint addresses 1-year changes in cardiovascular function (peak VO2 during cardiopulmonary exercise testing) and quality of life (Short-Form-36 physical functioning scale). Prior to randomization, all included patients underwent a multimodal anti-obesity treatment for 6-12 months. Thereafter, patients were randomized and followed through month 12 to collect primary endpoints. Afterwards, patients in the lifestyle group could opt for surgery, and final visit was scheduled for all patients 24 months after randomization. The study was initially designed in 2008 as part of several interdisciplinary studies for a targeted grant and received a positive vote from the responsible ethics committee. Prior the actual start of the study in July 2011, the initial study protocol and the patient informed consent were updated and further specified. This amendment was submitted to the Ethics Committee on June 9, 2011, with a positive vote on June 30, 2011 (Amendment 1). An Amendment 2 was submitted to Ethics Committee on 08.10.2014 (positive vote 16.12.2014) to adjust randomization (previously 1:1 to the two study arms) for an unequal drop-out rate in the two study arms with higher rate in the intensified lifestyle modification. In addition, few secondary endpoints were adapted and the role of the principal investigator changed from Prof. Stefan Frantz to Prof. Martin Fassnacht. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01352403
Study type	Interventional
Source	University of Wuerzburg
Contact
Status	Completed
Phase	N/A
Start date	July 4, 2011
Completion date	January 28, 2019

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms