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Dextrose Concentration Decline Rate in Vivo

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06128122
Enrollment
1
Registered
2023-11-13
Start date
2023-12-19
Completion date
2024-01-08
Last updated
2024-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dextrose Concentration

Keywords

Dextrose, Hydrodissection, Proliferation

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.

Interventions

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I.V. catheter will be placed in the suprapatellar pouch, by which samples of synovial fluid from the pouch will be withdrawn and analyzed for glucose level.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

Sponsors

Dr. Dean Reeves Clinic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

Dextrose curve production from a single individual

Eligibility

Sex/Gender
MALE
Age
69 Years to 69 Years
Healthy volunteers
Yes

Inclusion criteria

Able to be relatively immobile for intermittent measurement of dextrose levels

Exclusion criteria

Diabetic

Design outcomes

Primary

MeasureTime frameDescription
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 hoursDextrose 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 measurementDextrose levels at time zero and every 5 minutes after injection subcutaneously

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026