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

Shoulder Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03328975
• Other study ID #: PRO17070506
• Status: Withdrawn
• Phase: N/A
• First received: September 17, 2017
• Last updated: October 29, 2017
• Start date: November 1, 2017
• Est. completion date: November 1, 2022

Study information

• Verified date: October 2017
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Insulin-dependent Diabetics
• Shoulder Injuries
• Shoulder Injury

Intervention

Drug:
• Dexamethasone
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.

Other:
• Placebo
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks