Back to resultsAn Evaluation of Blood Glucose Levels and Insulin Requirement After Subacromial Corticosteroid Injection in Insulin Dependent Diabetics
Primary Purpose
Shoulder Injury, Insulin-dependent Diabetics
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dexamethasone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Injury
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Dexamethasone
Placebo
Arm Description
Group 1 will receive an injection of 4mg of dexamethasone 4 mL of 1% lidocaine.
Group 2 will receive an injection of 5 mL of 1% lidocaine (placebo).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03328975
First Posted
September 17, 2017
Last Updated
October 29, 2017
Sponsor
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT03328975
Brief Title
An Evaluation of Blood Glucose Levels and Insulin Requirement After Subacromial Corticosteroid Injection in Insulin Dependent Diabetics
Official Title
An Evaluation of Blood Glucose Levels and Insulin Requirement After Subacromial Corticosteroid Injection in Insulin Dependent Diabetics
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Withdrawn
Why Stopped
PI decided to withdraw study
Study Start Date
November 1, 2017 (Anticipated)
Primary Completion Date
November 1, 2021 (Anticipated)
Study Completion Date
November 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Injury, Insulin-dependent Diabetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone
Arm Type
Active Comparator
Arm Description
Group 1 will receive an injection of 4mg of dexamethasone 4 mL of 1% lidocaine.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Group 2 will receive an injection of 5 mL of 1% lidocaine (placebo).
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Corticosteroid
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention 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.
Primary Outcome Measure Information:
Title
Can diabetic patients maintain their blood glucose in a normal range after receiving a corticosteroid injection?
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Learn more about this trial
An Evaluation of Blood Glucose Levels and Insulin Requirement After Subacromial Corticosteroid Injection in Insulin Dependent Diabetics
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