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

NCT03328975 | Withdrawn

• 1 other identifier: PRO17070506
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Shoulder Injury; Insulin-dependent Diabetics

Outcome Measures

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.

  4 weeks

Study Arms (2)

Dexamethasone

ACTIVE COMPARATOR

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

Drug: Dexamethasone

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Dexamethasone DRUG

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

Dexamethasone

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous corticosteroid injection within the past 6 months
• Active infection
• Pregnant or plan on becoming pregnant
• Previous adverse event with corticosteroid or lidocaine use

Sponsors & Collaborators

• University of Pittsburgh: lead

MeSH Terms

Conditions

Shoulder Injuries

Interventions

Dexamethasone; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 17, 2017
• First Posted: November 1, 2017
• Study Start: November 1, 2017
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2022
• Last Updated: November 1, 2017

Record last verified: 2017-10