ClinicalTrials.gg
WithdrawnNCT03328975Updated Nov 1, 2017

An Evaluation of Blood Glucose Levels and Insulin Requirement After Subacromial Corticosteroid Injection in Insulin Dependent Diabetics

An interventional study of Dexamethasone and Placebo in Shoulder Injury and Insulin-dependent Diabetics, sponsored by University of Pittsburgh. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-01.

Sponsored by University of Pittsburgh · Not applicable, Interventional, and Treatment

Why this study was withdrawn
PI decided to withdraw study
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Shoulder Injury
  • Insulin-dependent Diabetics

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03

In context

Shoulder Injuries

118 studies on the registry are indexed under Shoulder Injuries; 32 are open to participants now.

Browse Shoulder Injuries studies →

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,420 studies on the registry; 169 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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
  • less than or equal to 7.5

Exclusion criteria

Exclusion Criteria

  • Previous injection within the past 6 months
  • Active infection
  • Pregnant or plan on becoming pregnant
  • Previous adverse event with corticosteroid or lidocaine use
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    Dexamethasone

    Group 1 will receive an injection of 4mg of dexamethasone 4 mL of 1% lidocaine.

    Drug: Dexamethasone

  • Placebo comparator
    Placebo

    Group 2 will receive an injection of 5 mL of 1% lidocaine (placebo).

    Other: Placebo

Interventions

  • 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.

    Also known as: Corticosteroid

  • OtherPlacebo

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4 weeks

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2017; primary completion for Nov 2021, 48 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 17, 2017
First posted
Nov 1, 2017
StartEst.
Nov 1, 2017
Primary completionEst.
Nov 1, 2021
CompletionEst.
Nov 1, 2022
Last update
Nov 1, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03328975
Responsible party
Bryson Lesniak (MD, University of Pittsburgh) — Principal investigator
First posted
Nov 1, 2017
Start date
Nov 1, 2017 (estimated)
Primary completion
Nov 1, 2021 (estimated)
Completion
Nov 1, 2022 (estimated)
Last update
Nov 1, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Dexamethasone

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