Osteoarthritis, KneeNCT06228911
Increased Blood Glucose Levels After Steroid Injection
A study testing steroid (triamcinolone) in people with Osteoarthritis, Knee and Diabete Type 2, run by Syrian Private University at 1 site in Syria.
Trial summary
a sample of 600 patients diagnosed as Knee osteoarthritis injected with 40 mg triamcinolone, recorded their morning fasting blood glucose levels for 7 days before injection used as the baseline blood glucose level, which was compared with FBS levels for 14 days after steroid injection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Diabete Type 2
- What is being tested?
- steroid (triamcinolone)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteSyria
- Study dates
- 15 Jan 2020to 15 Sep 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years, patients with knee osteoarthritis diagnosed according to American College of Rheumatology (ACR) Criteria (17), and grade1-3 in Kallgren-Laurence radiographic scale (18), whom failed to response to medical treatment including paracetamol and nonsteroidal anti-inflammatory medication, and to physical therapy, checking their blood glucose values daily.
Who cannot join
- Patients who were unable to provide consent, patients had any contraindications to corticosteroids, patients who had received oral corticosteroid in the past 6 months or corticosteroid injection in the previous 3 months, patients who had no monitoring HbA1c level before injection or also whom had not monitor blood glucose levels before or after injection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Increased Blood Glucose Levels After Steroid Injection Into Osteoarthritic Knee in Diabetic Patients' Type 2
a sample of 600 patients diagnosed as Knee osteoarthritis injected with 40 mg triamcinolone, recorded their morning fasting blood glucose levels for 7 days before injection used as the baseline blood glucose level, which was compared with FBS levels for 14 days after steroid injection. Our study compared the differences in blood glucose changes between HbA1c >7% and HbA1c ≤7% groups and those between insulin and non-insulin treated groups.
- Conditions
- Osteoarthritis, Knee, Diabete Type 2
- Being tested
- steroid (triamcinolone)
- Medical subject headings
- Osteoarthritis, Knee, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
steroid (triamcinolone)Drug
triamcinolone is a synthetic corticosteroid medication used topically to treat various skin conditions, to relieve the discomfort of mouth sores, and by injection into joints to treat various joint conditions
| Study group | Role | What they receive |
|---|---|---|
| insulin treated group | Experimental | Not described Receives: Drug: steroid (triamcinolone) |
| non-insulin treated groups | Experimental | Not described Receives: Drug: steroid (triamcinolone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
high blood glucose
glucose increases after steroid dose
Measured: 3 years
low blood glucose
glucose decreases after steroid dose
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start15 Jan 2020
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syrian Private University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diaa Haj Ali, Syrian Private University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228911
- Sponsor's protocol ID
- GH; 5615
- Status last verified
- Jan 2024
- First submitted
- 18 Jan 2024
- Last updated
- 30 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increased Blood Glucose Levels After Steroid Injection Into Osteoarthritic Knee in Diabetic Patients' Type 2
- ClinicalTrials.gov ID
- NCT06228911
- Acronym / sponsor ID
- GH; 5615
- Conditions
- Osteoarthritis, Knee, Diabete Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Syrian Private UniversityUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 29 Jan 2024 (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 sample of 600 patients diagnosed as Knee osteoarthritis injected with 40 mg triamcinolone, recorded their morning fasting blood glucose levels for 7 days before injection used as the baseline blood glucose level, which was compared with FBS levels for 14 days after steroid injection. Our study compared the differences in blood glucose changes between HbA1c >7% and HbA1c ≤7% groups and those between insulin and non-insulin treated groups.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| insulin treated group | Experimental | Drug: steroid (triamcinolone) |
| non-insulin treated groups | Experimental | Drug: steroid (triamcinolone) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age > 18 years, patients with knee osteoarthritis diagnosed according to American College of Rheumatology (ACR) Criteria (17), and grade1-3 in Kallgren-Laurence radiographic scale (18), whom failed to response to medical treatment including paracetamol and nonsteroidal anti-inflammatory medication, and to physical therapy, checking their blood glucose values daily.
Key exclusion criteria (1 listed)
- Patients who were unable to provide consent, patients had any contraindications to corticosteroids, patients who had received oral corticosteroid in the past 6 months or corticosteroid injection in the previous 3 months, patients who had no monitoring HbA1c level before injection or also whom had not monitor blood glucose levels before or after injection.
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 |
|---|---|---|
| steroid (triamcinolone)triamcinolone is a synthetic corticosteroid medication used topically to treat various skin conditions, to relieve the discomfort of mouth sores, and by injection into joints to treat various joint conditions | Drug | insulin treated group, non-insulin treated groups |
Primary outcome
high blood glucose
Time frame: 3 years
glucose increases after steroid dose
low blood glucose
Time frame: 3 years
glucose decreases after steroid dose
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 30 Jan 2024.
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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?
A study testing steroid (triamcinolone) in people with Osteoarthritis, Knee and Diabete Type 2, run by Syrian Private University at 1 site in Syria.
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 30 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 Syria. 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?
high blood glucose (time frame: 3 years). 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 30 Jan 2024.