Severe Obesity: Bariatric Surgery vs. Life-Style-Intervention Wurzburg Adipositas Study - WAS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- Change of peak VO2 to assess cardiorespiratory performance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •BMI >40 kg/m2 or BMI >35 kg/m2 with severe comorbidities
- •Indication for Roux-en-Y gastric bypass surgery
- •Ability to perform cardiopulmonary exercise testing (CPET)
- •Written informed consent
排除标准
- •Pregnancy or breast feeding
- •Unstable angina pectoris
- •Life expectancy <12 months
- •Endocrine or psychiatric disorder as cause of obesity
- •Systemic glucocorticoid treatment (with exception of glucocorticoid replacement therapy)
- •Abuse of drugs or alcohol within the last 5 years
- •Inability to attend regular study visits for logistic reasons
- •Participation in competing trials
结局指标
主要结局
Change of peak VO2 to assess cardiorespiratory performance
时间窗: 12 months after surgery / lifestyle intervention
Change of peak V O2 (measured in ml/min/kg bw) in cardiopulmonary exercise testing (CPET)
Change in physical functioning scale (PFS) of the SF-36 to assess quality of life
时间窗: 12 months after surgery / lifestyle intervention
Change of quality of life measured with physical functioning scale (PFS) of the SF-36 questionnaire (Short Form health survery 36). The score ranges from 0-100 and higher values correspond to better quality of life.
次要结局
- Change in left ventricular mass (index)(12 and 24 months after bariatric surgery / lifestyle intervention)
- Change in physical performance(12 and 24 months after bariatric surgery / lifestyle intervention)
- Change in brain morphology(12 and 24 months after bariatric surgery / lifestyle intervention)
- Change in brain oxygenation(12 and 24 months after bariatric surgery / lifestyle intervention)
- Change in left ventricular systolic function(12 and 24 months after bariatric surgery / lifestyle intervention)
- Change in depressed mood(12 and 24 months after bariatric surgery / lifestyle intervention)
- Change in health related quality of life (other domains than physical functioning scale)(12 and 24 months after bariatric surgery / lifestyle intervention)
- Changes in left atrial dimensions(12 and 24 months after bariatric surgery / lifestyle intervention)
- Changes in left ventricular dimensions(12 and 24 months after bariatric surgery / lifestyle intervention)
- Change in brain activity(12 and 24 months after bariatric surgery / lifestyle intervention)
- Change in depression(12 and 24 months after bariatric surgery / lifestyle intervention)
- Change in liver stiffness(12 and 24 months after bariatric surgery / lifestyle intervention)
- Change in burden of comorbidities (dyslipidemia)(12 and 24 months after bariatric surgery / lifestyle intervention)
- Change in burden of comorbidities (type 2 diabetes mellitus)(12 and 24 months after bariatric surgery / lifestyle intervention)
- Change in burden of comorbidities (arterial hypertension)(12 and 24 months after bariatric surgery / lifestyle intervention)
- Change in prevalence of left ventricular diastolic dysfunction(12 and 24 months after bariatric surgery / lifestyle intervention)
- Change in left ventricular function(12 and 24 months after bariatric surgery / lifestyle intervention)
- Change in cardiac lipid content(12 and 24 months after bariatric surgery / lifestyle intervention)
- Change in liver triglyceride content(12 and 24 months after bariatric surgery / lifestyle intervention)
- Change in NYHA functional class(12 and 24 months after bariatric surgery / lifestyle intervention)
研究者
Martin Fassnacht
Chair of Department of Endocrinology and Diabetology
University of Wuerzburg