Weight Reduction Surgery Followed by Kidney Transplantation for Patients with Class III Obesity and Renal Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Ability to reach medical suitability for renal transplant within 18 months after initiating treatment and the change and trajectory of health-related quality of life (HRQOL)
研究概览
简要总结
Gastric Bypass followed by renal transplantation is superior to medical management followed by renal transplant for patients with severe obesity and renal failure.
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 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index 40-55 kg/m2
- •Age less than 60 years
- •Available support person
- •Adequate insurance
- •All other criteria required for renal transplantation
排除标准
- •Schizophrenia
- •Bipolar disorder
- •Crohn's disease
- •Human Immunodeficiency Virus
- •Cirrhosis
- •Prior weight loss surgery
- •Prior mesh hernia repair
- •Prior anti-reflux surgery
- •Inability to walk 200 feet
- •Significant coronary disease
- •Significant lung disease - Fixed expiratory volume 1 less than 75% or on oxygen
- •Addiction to alcohol or drugs
- •Inability to quit smoking
- •Jehovah's witness
- •Non-compliance with dialysis regimen
- •Previous renal transplant
- •Non-English speaking
研究组 & 干预措施
Medical Weight Loss Management
Patients will receive best practices medical management for weight loss under current institutional protocols
干预措施: Weight Loss Program (Other)
Surgical Gastric Bypass
Patients will undergo surgical gastric bypass according to standard institutional protocols
干预措施: Gastric Bypass (Procedure)
结局指标
主要结局
Ability to reach medical suitability for renal transplant within 18 months after initiating treatment and the change and trajectory of health-related quality of life (HRQOL)
时间窗: 18 months
Outcomes will be measured based on weight loss and a variety of validated surveys and questionnaires to measure HRQOL
次要结局
- Weight loss(5 years)
- Nutritional status(5 years)
- All-cause mortality(5 years)
- Health care utilization(5 years)
- Hormonal and metabolic status(5 years)
- Surgical outcomes(5 years)
- Development or regression of diabetes(5 years)
- Development or regression of other comorbidities(5 years)
研究者
Seth Karp
Professor
Vanderbilt University Medical Center