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

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

Sponsors

Lead sponsor: University of Pittsburgh

Source University of Pittsburgh
Brief 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.

Overall Status Withdrawn
Start Date November 1, 2017
Completion Date November 1, 2022
Primary Completion Date November 1, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Can diabetic patients maintain their blood glucose in a normal range after receiving a corticosteroid injection? 4 weeks
Condition
Intervention

Intervention type: Drug

Intervention name: Dexamethasone

Description: 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.

Arm group label: Dexamethasone

Other name: Corticosteroid

Intervention type: Other

Intervention name: Placebo

Description: 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.

Arm group label: Placebo

Eligibility

Criteria:

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

- Hemoglobin A1c less than or equal to 7.5

Exclusion Criteria

- Previous corticosteroid injection within the past 6 months

- Active infection

- Pregnant or plan on becoming pregnant

- Previous adverse event with corticosteroid or lidocaine use

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Verification Date

October 2017

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: University of Pittsburgh

Investigator full name: Bryson Lesniak

Investigator title: MD

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Dexamethasone

Arm group type: Active Comparator

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

Arm group label: Placebo

Arm group type: Placebo Comparator

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

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov