NCT06075511撤回不适用
Prospective Study to Assess Fitness in Patients with Renal Failure Undergoing Sleeve Gastrectomy - PROFIT
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 主要终点
- Change in 6-minute walk distance (6MWD)
研究概览
简要总结
This research study is being conducted to collect information to improve the outcomes of patients who have renal failure and are scheduled to have a sleeve gastrectomy.
详细描述
We will collect information on changes in physical performance, activity, blood pressure and glucose metabolism, body composition, and the quality of life prior to and three months after sleeve gastrectomy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Kidney transplant candidates with obesity.
- •Accepted for sleeve gastrectomy (SG).
- •Accepted for kidney transplantation if criteria are met after SG.
排除标准
- •Not undergoing sleeve gastrectomy.
- •Unable to connect through telehealth technology.
- •History of medical non-adherence that can affect adherence to the protocol.
- •Any other medical condition that in the opinion of the Principal Investigators warrants exclusion for safety reasons.
结局指标
主要结局
Change in 6-minute walk distance (6MWD)
时间窗: Baseline, 12 weeks
Total distance walked at a self-selected pace reported in meters
次要结局
- Change in Short Physical Performance Battery (SPPB) score(Baseline, 12 weeks)
- Change in total step count(Baseline, 12 weeks)
- Change in quality of life(Baseline, 12 weeks)
- Change in glucose metrics(Baseline, 12 weeks)
- Change in blood pressure(Baseline, 12 weeks)
- change in insulin, C peptide and glucose metrics(Baseline, 12 weeks)
研究者
Aleksandra Kukla
Principal Investigator
Mayo Clinic
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