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.

Study Timeline

• Study First Submitted: 2023-11-01
• Study First Submitted QC: 2023-11-09
• Study First Posted: 2023-11-13
• Study Start: 2023-12-19
• Status Verified: 2024-01
• Primary Completion: 2024-01-04
• Study Completion: 2024-01-08
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-09

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

Name	Time	Method
Dextrose levels in synovial fluid	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	Continuous glucose measurement	Dextrose levels at time zero and every 5 minutes after injection subcutaneously

Trial Locations

Locations (1)

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