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临床试验/NCT06128122
NCT06128122已完成不适用

Dextrose Concentration Decline Rate in Vivo After Intraarticular Knee and Subcutaneous Injection

Dr. Dean Reeves Clinic2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2023年12月19日最近更新:
适应症

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

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

发起方
Dr. Dean Reeves Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Dean Reeves

Principal Investigator

Dr. Dean Reeves Clinic

研究点 (2)

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