跳至主要内容
临床试验/NCT00994669
NCT00994669已完成不适用

Development of a Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients

The University of Texas Medical Branch, Galveston1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2009年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
1
主要终点
Assessment of the slope of terminal D-3MH/3MH decay curve post-dosing.

研究概览

简要总结

The long-term objective of this research is to develop a non-invasive approach for early assessment of which patients are at high risk for future development of skeletal muscle atrophy. The investigators hypothesize that the rate constant for the terminal portion of the isotope decay curve following ingestion of a single oral dose of deuterated-3-methylhistidine (D-3MH) provides an accurate measure of this increased risk and that this rate constant can be measured non-invasively from timed spot urine samples. In addition, the investigators hypothesize that ingestion of a meat-containing meal will stimulate synthesis of skeletal muscle proteins to a greater extent than a non-meat-containing meal.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
30 Years 至 85 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 30-85 years
  • Body Mass Index (BMI) <30 kg/m2

排除标准

  • Uncontrolled hypertension
  • Glomerular filtration rate less than 60 mL/min/1.73 m2
  • History of recurrent gastrointestinal bleeding
  • Unable or unwilling to provide informed consent
  • Ongoing anti-coagulant therapy

结局指标

主要结局

Assessment of the slope of terminal D-3MH/3MH decay curve post-dosing.

时间窗: Post-dosing 12 to 22 hours

Assess the slope of the terminal D-3MH/3MH decay curve for the post-dosing time period as calculated using plasma or urine samples and after a meat-containing or meat-free test meal.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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