Dextrose ConcentrationNCT06128122
Dextrose Concentration Decline Rate in Vivo
A study testing Intrarticular and subcutaneous dextrose injection with timed measurement of dextrose levels in people with Dextrose Concentration, run by Dr. Dean Reeves Clinic at 1 site in United States.
Trial summary
Measuring the speed of decrease in dextrose concentration to help design more accurate in vitro studies Read more about this study
- Who is it for?
- Ages 69 to 69 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dextrose Concentration
- What is being tested?
- Intrarticular and subcutaneous dextrose injection with timed measurement of dextrose levels
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2023to 8 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 69 to 69 years
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Able to be relatively immobile for intermittent measurement of dextrose levels
Who cannot join
- Diabetic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Dextrose Concentration
- Being tested
- Intrarticular and subcutaneous dextrose injection with timed measurement of dextrose levels
- Keywords
- Dextrose, Hydrodissection, Proliferation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrarticular and subcutaneous dextrose injection with timed measurement of dextrose levelsProcedure or surgery
Also called Glucose injection (Dextrose is the form of glucose that humans can metabolize)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Intrarticular and subcutaneous dextrose injection with timed measurement of dextrose levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dextrose levels in synovial fluid
Dextrose level in synovial fluid of the knee, beginning 1/2 hour after intraarticular injection
Measured: 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
Measured: Continuous glucose measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start19 Dec 2023
- Primary completion4 Jan 2024
- Study completion8 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dextrose ConcentrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Dextrose curve production from a single individual
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Dean Reeves Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Dean Reeves, Dr. Dean Reeves Clinic
- Investigators
- Kenneth D Reeves, M.D., Principal investigator, Dr. Dean Reeves Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06128122
- Sponsor's protocol ID
- Reeves-DexConc01
- Status last verified
- Jan 2024
- First submitted
- 1 Nov 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dextrose Concentration Decline Rate in Vivo After Intraarticular Knee and Subcutaneous Injection
- ClinicalTrials.gov ID
- NCT06128122
- Acronym / sponsor ID
- Reeves-DexConc01
- Conditions
- Dextrose Concentration
- Keywords
- Dextrose, Hydrodissection, Proliferation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Dr. Dean Reeves ClinicUniversity, hospital or other
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- 4 Jan 2024 (actual)
- Study completion
- 8 Jan 2024 (actual)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dextrose curve production from a single individual
| Arm | Type | Receives |
|---|---|---|
| Dextrose injection intraarticularly and in subcutaneous tissue with timed dextrose measurements | Experimental | Procedure: Intrarticular and subcutaneous dextrose injection with timed measurement of dextrose levelsStep 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. |
Who may qualify
- Ages
- 69 to 69 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Able to be relatively immobile for intermittent measurement of dextrose levels
Key exclusion criteria (1 listed)
- Diabetic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrarticular and subcutaneous dextrose injection with timed measurement of dextrose levelsAlso: Glucose injection (Dextrose is the form of glucose that humans can metabolize)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. | Procedure or surgery | Dextrose injection intraarticularly and in subcutaneous tissue with timed dextrose measurements |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth D Reeves, M.D. principal investigator
Dr. Dean Reeves Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrarticular and subcutaneous dextrose injection with timed measurement of dextrose levels in people with Dextrose Concentration, run by Dr. Dean Reeves Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.