DiabetesNCT04317404
Knee Steroid Injection and Blood Sugar Signatur
An observational study of Diabetes and Knee Osteoarthritis, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
A prospective, observational study assessing the relationship between HbA1c level and the post-injection blood glucose signature. Participants will be non-diabetic, pre-diabetic, non-insulin dependent and insulin dependent type 2 diabetic patients who will be receiving a knee steroid injection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Knee Osteoarthritis
- What is being tested?
- 40 mg Triamcinolone acetonide
- Type of treatment
- Injection or infusion
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2020to 30 Nov 2022
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Knee joint osteoarthritis requiring knee joint steroid injection
Who may be able to join
- Patients at the Parkland Outpatient Clinic
- Indication for unilateral knee joint steroid injection for the treatment of knee joint osteoarthritis
Who cannot join
- Less than 18 years old
- HbA1c > 12.0%
- steroid exposure in the 3 months prior to Visit 1
- 3 or more steroid injections in the preceding 12 months
- known contraindication to steroid injection (adverse reaction or allergy, active infection, INR > 3.0)
- lack of improvement with prior knee steroid injection
Show all 11Show fewer
- change in diabetic medication regimen in the last 1 month
- significant change in diet within the last 1 month
- current use of aspirin
- allergy to adhesive
- planned MRI, XR, or CT during the 2-week study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identifying Variables Associated With Steroid-Induced Hyperglycemia Following Intra-articular Knee Injections Among Diabetic Patients
A prospective, observational study assessing the relationship between HbA1c level and the post-injection blood glucose signature. Participants will be non-diabetic, pre-diabetic, non-insulin dependent and insulin dependent type 2 diabetic patients who will be receiving a knee steroid injection. All of them will be consented a week prior to the injection, when the CGM sensor will be applied to the back of the upper arm. This will be removed a week after the injection. KOOS survey as well as VAS will be administered. Adverse events (e.g., change in medication or hospitalization) will be monitored throughout the study.
- Conditions
- Diabetes, Knee Osteoarthritis
- Being tested
- 40 mg Triamcinolone acetonide
- Medical subject headings
- Diabetes Mellitus, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
40 mg Triamcinolone acetonideDrug
Unilateral knee steroid injection
| Study group | Role | What they receive |
|---|---|---|
| Diabetic with Knee Osteoarthritis | HbA1c between 6.5% - 12.0% in the 3 months prior to Visit 1 Receives: Drug: 40 mg Triamcinolone acetonide | |
| Pre-diabetic with Knee Osteoarthritis | HbA1c between 5.6% - 6.4% in the 3 months prior to Visit 1 Receives: Drug: 40 mg Triamcinolone acetonide | |
| Non-diabetic with Knee Osteoarthritis | HbA1c < 5.6% in the 3 months prior to Visit 1 Receives: Drug: 40 mg Triamcinolone acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-injection glucose levels
Blood glucose levels after injection of steroid to the knee
Measured: 1 week
Secondary outcomes (2)
Post-injection adverse events
Adverse events after injection of steroid to the knee
Measured: 1 week
KOOS Knee survey
KOOS Knee survey administered before and after steroid injection to the knee
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start1 Nov 2020
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Physical Medicine and Rehabilitation
- Responsible party
- Principal investigator, Reed Williams, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04317404
- Sponsor's protocol ID
- STU 2019-1202
- Status last verified
- Jan 2023
- First submitted
- 19 Mar 2020
- Last updated
- 18 Jan 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Variables Associated With Steroid-Induced Hyperglycemia Following Intra-articular Knee Injections Among Diabetic Patients
- ClinicalTrials.gov ID
- NCT04317404
- Acronym / sponsor ID
- STU 2019-1202
- Conditions
- Diabetes, Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Foundation for Physical Medicine and Rehabilitation
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 23 Mar 2020 (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.
A prospective, observational study assessing the relationship between HbA1c level and the post-injection blood glucose signature. Participants will be non-diabetic, pre-diabetic, non-insulin dependent and insulin dependent type 2 diabetic patients who will be receiving a knee steroid injection. All of them will be consented a week prior to the injection, when the CGM sensor will be applied to the back of the upper arm. This will be removed a week after the injection. KOOS survey as well as VAS will be administered. Adverse events (e.g., change in medication or hospitalization) will be monitored throughout the study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diabetic with Knee Osteoarthritis | – | Drug: 40 mg Triamcinolone acetonideHbA1c between 6.5% - 12.0% in the 3 months prior to Visit 1 |
| Pre-diabetic with Knee Osteoarthritis | – | Drug: 40 mg Triamcinolone acetonideHbA1c between 5.6% - 6.4% in the 3 months prior to Visit 1 |
| Non-diabetic with Knee Osteoarthritis | – | Drug: 40 mg Triamcinolone acetonideHbA1c < 5.6% in the 3 months prior to Visit 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Knee joint osteoarthritis requiring knee joint steroid injection
Key inclusion criteria (2 listed)
- Patients at the Parkland Outpatient Clinic
- Indication for unilateral knee joint steroid injection for the treatment of knee joint osteoarthritis
Key exclusion criteria (11 listed)
- Less than 18 years old
- HbA1c > 12.0%
- steroid exposure in the 3 months prior to Visit 1
- 3 or more steroid injections in the preceding 12 months
- known contraindication to steroid injection (adverse reaction or allergy, active infection, INR > 3.0)
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 |
|---|---|---|
| 40 mg Triamcinolone acetonideUnilateral knee steroid injection | Drug | Diabetic with Knee Osteoarthritis, Non-diabetic with Knee Osteoarthritis, Pre-diabetic with Knee Osteoarthritis |
Primary outcome
Post-injection glucose levels
Time frame: 1 week
Blood glucose levels after injection of steroid to the knee
2 secondary outcomes
Post-injection adverse events
Time frame: 1 week
KOOS Knee survey
Time frame: 2 weeks
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 18 Jan 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Knee Osteoarthritis, run by University of Texas Southwestern Medical Center 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 2 inclusion and 11 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 18 Jan 2023. 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?
Post-injection glucose levels (time frame: 1 week). 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 18 Jan 2023.