Effects of Nutritional Supplementation on Protein and Energy Homeostasis in Malnourished Chronic Hemodialysis Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- net muscle protein balance
研究概览
简要总结
The goal of this study is to evaluate the metabolic effects of concomitant use of three consecutive doses of recombinant human growth hormone over three days and exercise during continuous nutrient infusion in chronic hemodialysis patients. We would also like to evaluate the metabolic effects of nutritional supplementation alone without the additional anabolic strategies.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •On hemodialysis for more than 6 months, on a thrice weekly hemodialysis program;
- •Adequately dialyzed (Kt/V > 1.4).
排除标准
- •Patients unable to perform exercise.
- •Pregnant women.
- •Severe unstable underlying disease besides commonly associated with ESRD. Cardiac patients that are stable will be included.
- •Patients hospitalized within the last month prior to the study.
- •Patients with recirculation detected on the AV graft.
- •Patients receiving steroids and/or other immunosuppressive agents
研究组 & 干预措施
1
nutrition supplementation, recombinant human growth hormone, and exercise
干预措施: nutritional supplement (Dietary Supplement)
1
nutrition supplementation, recombinant human growth hormone, and exercise
干预措施: recombinant human growth hormone (rcGH) (Drug)
1
nutrition supplementation, recombinant human growth hormone, and exercise
干预措施: exercise (Behavioral)
2
nutrition supplementation only
干预措施: nutritional supplement (Dietary Supplement)
结局指标
主要结局
net muscle protein balance
时间窗: 10 hours
次要结局
- net whole body protein balance(10 hours)
研究者
Alp Ikizler
Professor
Vanderbilt University