Dextrose Concentration Decline Rate in Vivo

Study Overview
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Brief Summary
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Measuring the speed of decrease in dextrose concentration to help design more accurate in vitro studies

Detailed Description
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Rationale: In vitro studies of the potential mechanism of action of therapeutic dextrose (right-handed form of glucose than humans and animals can metabolize) commonly place human or animal cells in a dextrose 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.

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

Conditions
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Dextrose Concentration

Intervention / Treatment
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* Procedure: Intrarticular and subcutaneous dextrose injection with timed measurement of dextrose levels


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to be relatively immobile for intermittent measurement of dextrose levels Exclusion Criteria: Diabetic

Ages Eligible for Study
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Minimum Age: 69 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Dextrose curve production from a single individual
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dextrose injection intraarticularly and in subcutaneous tissue with timed dextrose measurements<br>Step One: Injection of 30 ml of D12.5% in the knee anteromedially with knee flexed. Placement of IV catheter into the suprapatellar pouch, and secure catheter. Withdraw and analyze samples for dextrose levels at 15-minute intervals. Step Two: Inject 3 ml of D5W subcutaneously. Place Dexcom G7 sensor at the site of injection. Measure dextrose levels every 5 minutes on smartphone. | Procedure: Intrarticular and subcutaneous dextrose injection with timed measurement of dextrose levels<br>* 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.<br>* Other names: Glucose injection (Dextrose is the form of glucose than humans can metabolize);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dextrose levels in synovial fluid | Dextrose level in synovial fluid of the knee, beginning 1/2 hour after intraarticular injection | 0.5, 1, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5. 7.0, 7.5, and 8.0 hours. | 
| Dextrose level in subcutaneous tissue | Dextrose levels subcutaneously, beginning 1/2 hour after subcutaneous injection | 1, 1.5, 2, 2.5, 3, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, and 8.0 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dextrose, Hydrodissection, Proliferation