Shoulder InjuryNCT03328975
An Evaluation of Blood Glucose Levels and Insulin Requirement After Subacromial Corticosteroid Injection in Insulin Dependent Diabetics
A study testing Dexamethasone in people with Shoulder Injury and Insulin-dependent Diabetics, run by University of Pittsburgh.
Trial summary
The overall purpose of this study is to evaluate the effect of a corticosteroid shoulder injection on glucose levels in insulin-dependent diabetic men and women. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Injury, Insulin-dependent Diabetics
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2017to 1 Nov 2022
- 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
- Insulin-dependent diabetic
- Age 18+
- Shoulder pain for over 4 weeks duration that is uncontrolled with activity modification or nonsteroidal anti-inflammatory drugs
- Use of glucometer for blood sugar monitoring
- Well controlled blood glucose levels
- Hemoglobin A1c less than or equal to 7.5
Who cannot join
- Previous corticosteroid injection within the past 6 months
- Active infection
- Pregnant or plan on becoming pregnant
- Previous adverse event with corticosteroid or lidocaine use
About this study
The overall purpose of this study is to evaluate the effect of a corticosteroid shoulder injection on glucose levels in insulin-dependent diabetic men and women.
- Conditions
- Shoulder Injury, Insulin-dependent Diabetics
- Being tested
- Dexamethasone, Placebo
- Medical subject headings
- Shoulder Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Corticosteroid
The overall purpose of this study is to evaluate the effect of a corticosteroid shoulder injection on glucose levels in insulin-dependent diabetic men and women.
PlaceboOther
the placebo group will not receive the corticosteroid medication in their injection to treat the inflammation and pain in their shoulder. Instead, they will receive an injection of 5 mL lidocaine only.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Active comparator | Group 1 will receive an injection of 4mg of dexamethasone 4 mL of 1% lidocaine. Receives: Drug: Dexamethasone |
| Placebo | Placebo comparator | Group 2 will receive an injection of 5 mL of 1% lidocaine (placebo). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Can diabetic patients maintain their blood glucose in a normal range after receiving a corticosteroid injection?
The main outcome variable in this study is to determine what effects, if any, a corticosteroid injection has on the ability of diabetic patients to maintain their blood glucose in a normal range. This will allow for better patient education when discussing the risks of corticosteroid injections and allow for improved post-injection care of patients.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start1 Nov 2017 (estimated)
- Primary completion1 Nov 2021 (estimated)
- Study completion1 Nov 2022 (estimated)
Why it stopped: PI decided to withdraw study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder InjuryStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bryson Lesniak, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03328975
- Sponsor's protocol ID
- PRO17070506
- Status last verified
- Oct 2017
- First submitted
- 17 Sep 2017
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Blood Glucose Levels and Insulin Requirement After Subacromial Corticosteroid Injection in Insulin Dependent Diabetics
- ClinicalTrials.gov ID
- NCT03328975
- Acronym / sponsor ID
- PRO17070506
- Conditions
- Shoulder Injury, Insulin-dependent Diabetics
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI decided to withdraw study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 1 Nov 2017 (estimated)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 1 Nov 2017 (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.
The overall purpose of this study is to evaluate the effect of a corticosteroid shoulder injection on glucose levels in insulin-dependent diabetic men and women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Active comparator | Drug: DexamethasoneGroup 1 will receive an injection of 4mg of dexamethasone 4 mL of 1% lidocaine. |
| Placebo | Placebo comparator | Other: PlaceboGroup 2 will receive an injection of 5 mL of 1% lidocaine (placebo). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Insulin-dependent diabetic
- Age 18+
- Shoulder pain for over 4 weeks duration that is uncontrolled with activity modification or nonsteroidal anti-inflammatory drugs
- Use of glucometer for blood sugar monitoring
- Well controlled blood glucose levels
Key exclusion criteria (4 listed)
- Previous corticosteroid injection within the past 6 months
- Active infection
- Pregnant or plan on becoming pregnant
- Previous adverse event with corticosteroid or lidocaine use
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 |
|---|---|---|
| DexamethasoneAlso: CorticosteroidThe overall purpose of this study is to evaluate the effect of a corticosteroid shoulder injection on glucose levels in insulin-dependent diabetic men and women. | Drug | Dexamethasone |
| Placebothe placebo group will not receive the corticosteroid medication in their injection to treat the inflammation and pain in their shoulder. Instead, they will receive an injection of 5 mL lidocaine only. | Other | Placebo |
Primary outcome
Can diabetic patients maintain their blood glucose in a normal range after receiving a corticosteroid injection?
Time frame: 4 weeks
The main outcome variable in this study is to determine what effects, if any, a corticosteroid injection has on the ability of diabetic patients to maintain their blood glucose in a normal range. This will allow for better patient education when discussing the risks of corticosteroid injections and allow for improved post-injection care of patients.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone in people with Shoulder Injury and Insulin-dependent Diabetics, run by University of Pittsburgh.
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 6 inclusion and 4 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: withdrawn, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Can diabetic patients maintain their blood glucose in a normal range after receiving a corticosteroid injection? (time frame: 4 weeks). 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 1 Nov 2017.