Koschker Ann-Cathrin, Warrings Bodo, Morbach Caroline, Seyfried Florian, Rickert Nicole, Jung Pius, Geier Andreas, Dischinger Ulrich, Krauthausen Maike, Herrmann Martin J, Stier Christine, Frantz Stefan, Malzahn Uwe, Störk Stefan, Fassnacht Martin
Division of Endocrinology and Diabetology, Department of Internal Medicine I, University Hospital, University of Würzburg, Würzburg, Germany.
Comprehensive Heart Failure Center, University & University Hospital Würzburg, Würzburg, Germany.
Endocr Connect. 2022 Feb 9;11(2):e210338. doi: 10.1530/EC-21-0338.
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. The open, randomized controlled Würzburg Adipositas Studie (WAS) trial compares the effects of Roux-en-Y gastric bypass (RYGB) vs 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 the quality of life (QoL) (Short-Form-36 physical functioning scale). Prior to randomization, all included patients underwent a multimodal anti-obesity treatment for 6-12 months. Thereafter, the patients were randomized and followed through month 12 to collect the primary endpoints. Afterwards, patients in the lifestyle group could opt for surgery, and final visit was scheduled for all patients 24 months after randomization. Sample size calculation suggested to enroll 90 patients in order to arrive at minimally 22 patients per group evaluable for the primary endpoint. Secondary objectives were to quantify changes in body weight, left ventricular hypertrophy, systolic and diastolic function (by echocardiography and cardiac MRI), functional brain MRI, psychometric scales, and endothelial and metabolic function. WAS enrolled 93 patients (72 women, median age 38 years, BMI 47.5 kg/m2) exhibiting a relevantly compromised exercise capacity (median peakVO2 18.3 mL/min/kg) and the QoL (median physical functioning scale 50). WAS is the first randomized controlled trial focusing on the effects of RYGB on cardiovascular function beyond hypertension. In addition, it will provide a wealth of high-quality data on the cerebral, psychiatric, hepatic, and metabolic function in obese patients after RYGB.
肥胖是一个迅速出现的健康问题，也是心血管疾病的既定风险因素。减肥手术能显著减轻体重并减轻肥胖的后遗症。开放性随机对照的维尔茨堡肥胖研究（WAS）试验比较了 Roux-en-Y 胃旁路术（RYGB）与心理治疗支持的生活方式改变对病态肥胖患者的影响。共同主要终点涉及心血管功能（心肺运动测试中的峰值 VO2）和生活质量（QoL）（简短 36 项身体功能量表）的 1 年变化。在随机分组之前，所有纳入的患者都接受了 6 - 12 个月的多模式抗肥胖治疗。此后，患者被随机分组并随访至第 12 个月以收集主要终点数据。之后，生活方式组的患者可以选择手术，所有患者在随机分组后 24 个月安排最后一次随访。样本量计算建议招募 90 名患者，以便每组至少有 22 名患者可用于评估主要终点。次要目标是量化体重、左心室肥厚、收缩和舒张功能（通过超声心动图和心脏磁共振成像）、功能性脑磁共振成像、心理量表以及内皮和代谢功能的变化。WAS 研究招募了 93 名患者（72 名女性，中位年龄 38 岁，BMI 47.5 kg/m²），这些患者的运动能力（中位峰值 VO2 为 18.3 mL/min/kg）和生活质量（中位身体功能量表评分为 50）明显受损。WAS 是第一项聚焦于 RYGB 对高血压以外心血管功能影响的随机对照试验。此外，它将提供大量关于肥胖患者接受 RYGB 术后大脑、精神、肝脏和代谢功能的高质量数据。
