Dextrose Concentration Decline Rate in Vivo

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

Measuring the speed of decrease in dextrose concentration to help design more accurate in vitro studies

Study Overview

• Status: Completed
• Conditions: Dextrose Concentration
• Intervention / Treatment: Procedure: Intrarticular and subcutaneous dextrose injection with timed measurement of dextrose levels

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 Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kenneth D Reeves, M.D.; Phone Number: 9139637750; Email: deanreevesmd@gmail.com
• Study Contact Backup: Name: Jordan R Atkins; Phone Number: 8167262843; Email: jordan.atkins@gmail.com

Study Locations

• United States
  • Kansas
    • Shawnee Mission, Kansas, United States, 66205
      • Kenneth Dean Reeves

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Able to be relatively immobile for intermittent measurement of dextrose levels

Exclusion Criteria:

Diabetic

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Dextrose injection intraarticularly and in subcutaneous tissue with timed dextrose measurements; 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. If catheter fails, aspirate directly from suprapatellar pouch. Step Two: Inject 1-3 ml of D5W into interstitial space about a functioning Dexcom G7 sensor. Measure dextrose levels every 5 minutes on a Dexcom receiver.

Procedure: Intrarticular 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.; Other Names: Glucose injection (Dextrose is the form of glucose that humans can metabolize)

What is the study measuring?

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, and 6.0 hours
Dextrose level in subcutaneous tissue (interstitial space) in upper arm or abdomen	Dextrose levels at time zero and every 5 minutes after injection subcutaneously	Continuous glucose measurement

Collaborators and Investigators

• Sponsor: Dr. Dean Reeves Clinic
• Investigators: Principal Investigator: Kenneth D Reeves, M.D., Dr. Dean Reeves Clinic

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2023
• Primary Completion (Actual): January 4, 2024
• Study Completion (Actual): January 8, 2024

Study Registration Dates

• First Submitted: November 1, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Hydrodissection; Dextrose; Proliferation
• Other Study ID Numbers: Reeves-DexConc01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No