Dextrose Concentration Decline Rate in Vivo

NCT06128122 | Completed DMC

• 1 other identifier: Reeves-DexConc01
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dextrose Concentration

Keywords

Dextrose; Hydrodissection; Proliferation

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Dextrose injection intraarticularly and in subcutaneous tissue with timed dextrose measurements

EXPERIMENTAL

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

Interventions

Intrarticular and subcutaneous dextrose injection with timed measurement of dextrose levels PROCEDURE

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I.V. catheter will be placed in the suprapatellar pouch, by which samples of synovial fluid from the pouch will be withdrawn and analyzed for glucose level.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

Also known as: Glucose injection (Dextrose is the form of glucose that humans can metabolize)

Dextrose injection intraarticularly and in subcutaneous tissue with timed dextrose measurements

Eligibility Criteria

• Age: 69 Years - 69 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Able to be relatively immobile for intermittent measurement of dextrose levels

You may not qualify if:

• Diabetic

Sponsors & Collaborators

• Dr. Dean Reeves Clinic: lead

Study Sites (1)

Kenneth Dean Reeves

Shawnee Mission, Kansas, 66205, United States

Location

MeSH Terms

Interventions

Glucose

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Kenneth D Reeves, M.D.

  Dr. Dean Reeves Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Dextrose curve production from a single individual

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 13, 2023
• Study Start: December 19, 2023
• Primary Completion: January 4, 2024
• Study Completion: January 8, 2024
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)