Dextrose Concentration Decline Rate in… | Clinical Trial

Key information

Conditions

Dextrose Concentration

Age range

69 year–69 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Kenneth Dean Reeves

Shawnee Mission, Kansas, 66205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Able to be relatively immobile for intermittent measurement of dextrose levels

Exclusion criteria

Diabetic

Treatment and study plan

Intrarticular and subcutaneous dextrose injection with timed measurement of dextrose levels

Procedure

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I.V. catheter will be placed in the suprapatellar pouch, by which samples of synovial fluid from the pouch will be withdrawn and analyzed for glucose level.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.

Other names: Glucose injection (Dextrose is the form of glucose that humans can metabolize)

Primary outcomes

Dextrose levels in synovial fluid

Time frame: 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

Time frame: Continuous glucose measurement

Dextrose levels at time zero and every 5 minutes after injection subcutaneously

Sponsors and collaborators

Lead sponsor

Dr. Dean Reeves Clinic

Other

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Nov 13, 2023
Registry last updated: Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.