Dextrose Concentration Decline Rate in Vivo After Intraarticular Knee and Subcutaneous Injection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Dextrose levels in synovial fluid
研究概览
简要总结
Measuring the speed of decrease in dextrose concentration to help design more accurate in vitro studies
详细描述
Rationale: In vitro studies of the potential mechanism of action of therapeutic dextrose injection commonly place human or animal cells in a dextrose (glucose) culture medium for a prolonged period of time, typically 24 hours, and expose them to high dextrose levels, typically 1-25% (1000- 25,000mg%). High glucose levels in culture media can cause cell death. Given that cellular apoptosis/death has not been shown to occur after therapeutic dextrose injection in vivo by histologic analysis, we expect that elevated glucose levels drop rapidly in vivo. In this study 12.5% dextrose will be injected intraarticularly (in the knee) and dextrose 5% will be injected subcutaneously, and dextrose level measurements will be obtained at timed intervals after each in order to produce a curve depicting the pattern and speed of decrease in dextrose levels after in vivo injection. In vitro studies can then utilize this information to alter the pattern and speed of decrease of dextrose levels to mimic in vivo conditions, and in so doing provide more useful data on potential mechanisms of therapeutic dextrose injection in soft tissue and joints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 69 Years 至 69 Years(Older Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Able to be relatively immobile for intermittent measurement of dextrose levels
排除标准
- 未提供
结局指标
主要结局
Dextrose levels in synovial fluid
时间窗: 0.5, 1, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, and 6.0 hours
Dextrose level in synovial fluid of the knee, beginning 1/2 hour after intraarticular injection
Dextrose level in subcutaneous tissue (interstitial space) in upper arm or abdomen
时间窗: Continuous glucose measurement
Dextrose levels at time zero and every 5 minutes after injection subcutaneously
次要结局
未报告次要终点
研究者
Dr. Dean Reeves
Principal Investigator
Dr. Dean Reeves Clinic
