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Dextrose Concentration Decline Rate in Vivo

Not Applicable
Completed
Conditions
Dextrose Concentration
Registration Number
NCT06128122
Lead Sponsor
Dr. Dean Reeves Clinic
Brief 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
1
Inclusion Criteria

Able to be relatively immobile for intermittent measurement of dextrose levels

Exclusion Criteria

Diabetic

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Dextrose levels in synovial fluid0.5, 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 abdomenContinuous glucose measurement

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Kenneth Dean Reeves

🇺🇸

Shawnee Mission, Kansas, United States

Kenneth Dean Reeves
🇺🇸Shawnee Mission, Kansas, United States

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