We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Corticosteroid Injections on Blood Glucose (CSI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05048264
Recruitment Status : Recruiting
First Posted : September 17, 2021
Last Update Posted : May 15, 2023
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to measure the effect of various corticosteroid and other anti-inflammatories administered to the glenohumeral joint in diabetic patients on resultant blood glucose readings.

Condition or disease
Diabetes Mellitus Steroid Diabetes Shoulder Pain

Detailed Description:

The purpose of this study is to measure the effect of various corticosteroid and other anti-inflammatories administered to the glenohumeral joint in diabetic patients on resultant blood glucose readings.

Corticosteroid injections (CSI) are frequently used in orthopedic settings in order to treat a wide array of orthopedic issues, including osteoarthritis, bursitis, tendinitis, and many others. The effect of diabetes on the musculoskeletal system and its role in orthopedic disease has been well-documented. Current evidence demonstrates that corticosteroids, even when administered through a local musculoskeletal injection, can lead to temporary increases in blood glucose. Ultrasound guidance was not explicitly used in any of the studies examining the impact of steroids on blood glucose. The utilization of ultrasound guidance has been shown to increase accuracy when performing injections into the subacromial space as well as the glenohumeral joint when compared to palpation/landmark-guided injections.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 124 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Corticosteroid Injections Administered Under Ultrasound Guidance to Diabetic Patients and the Effect on Blood Glucose
Actual Study Start Date : May 4, 2023
Estimated Primary Completion Date : May 4, 2025
Estimated Study Completion Date : May 4, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Diabetic shoulder patients receiving an anti-inflammatory injection


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in blood glucose measures [ Time Frame: Baseline & 2 weeks ]
    Reported daily glucose measures from baseline to two week after injection


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who has been clinically diagnosed with diabetes and receiving an anti-inflammatory injection in their shoulder joint.
Criteria

Inclusion Criteria:

  • Known diabetic patients ages 40-75 undergoing clinically indicated standard of care anti-inflammatory glenohumeral joint injection
  • Ability to perform daily blood glucose testing
  • Can receive and send text messages

Exclusion Criteria:

  • Previous joint arthroplasty
  • Corticosteroid injection at other sites in the body or in the shoulder within the past month
  • Systemic corticosteroid within the last month other than asthma inhaler
  • Anyone who are unable to read and/or understand English
  • Pregnant women (self-report)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05048264


Contacts
Layout table for location contacts
Contact: Duke Sports Medicine Research 9196842042 sportsmed_research@dm.duke.edu

Locations
Layout table for location information
United States, North Carolina
Duke Sports Science Institute Recruiting
Durham, North Carolina, United States, 27705
Principal Investigator: Anthony Ceraulo, MD         
Sponsors and Collaborators
Duke University
Investigators
Layout table for investigator information
Principal Investigator: Anthony Ceraulo, MD Duke University
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT05048264    
Other Study ID Numbers: Pro00108093
First Posted: September 17, 2021    Key Record Dates
Last Update Posted: May 15, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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.: Yes
Keywords provided by Duke University:
Diabetes
Corticosteroids
Injection
Shoulder
Pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Shoulder Pain
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations