Dextrose Concentration Decline Rate in Vivo

January 8, 2024 updated by: Dr. Dean Reeves, Dr. Dean Reeves Clinic

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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
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
Time Frame: Continuous glucose measurement
Dextrose levels at time zero and every 5 minutes after injection subcutaneously
Continuous glucose measurement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Dean Reeves Clinic

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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