NCT06128122

Dextrose Concentration Decline Rate in Vivo

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Dr. Dean Reeves Clinic · Academic / Other
• Sex: Male
• Age: 69 Years – 69 Years
• Healthy volunteers: Accepted

Summary

Measuring the speed of decrease in dextrose concentration to help design more accurate in vitro studies

Detailed description

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.

Conditions

• Dextrose Concentration

Interventions

Type	Name	Description
PROCEDURE	Intrarticular and subcutaneous dextrose injection with timed measurement of dextrose levels	Step one: 30 mL of 12.5%/0.1% lidocaine will be injected into the knee using an inferomedial approach. Using ultrasound guidance, a 20-gauge 2-inch I.V. catheter will be placed in the suprapatellar pouch, by which samples of synovial fluid from the pouch will be withdrawn and analyzed for glucose level. Step two: 3 mL of D5W will be injected into a marked spot on the back of the upper arm. A sensor/transmitter (Dexcom G7 Dexcom) is placed at the site of injection. The sensor/transmitter will begin providing dextrose levels at 5 minute intervals beginning one-half hour after placement of the sensor/transmitter, transmitted to a paired smart phone.

Timeline

• Start date: 2023-12-19
• Primary completion: 2024-01-04
• Completion: 2024-01-08
• First posted: 2023-11-13
• Last updated: 2024-01-09

Locations

1 site across 1 country: United States