Effect of Corticosteroid Injections on Blood Glucose (CSI)

December 15, 2023 updated by: Duke University

Corticosteroid Injections Administered Under Ultrasound Guidance to Diabetic Patients and the Effect on Blood Glucose

The purpose of this study is to measure the effect of various corticosteroids administered to the shoulder, knee and hip joints in diabetic patients on resultant blood glucose readings.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to measure the effect of various corticosteroids administered to the shoulder, knee, and hip joints 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 Type

Observational

Enrollment (Estimated)

55

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke Sports Science Institute
        • Principal Investigator:
          • Anthony Ceraulo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who has been clinically diagnosed with diabetes and receiving a corticosteroid injection in their shoulder, knee or hip joints.

Description

Inclusion Criteria:

  • Known diabetic patients ages 40-75 undergoing clinically indicated standard of care corticosteroid shoulder, knee and hip 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 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Diabetic patients receiving a corticosteroid injection of their shoulder, knee or hip joints.
There are no study-related interventions for this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in blood glucose measures
Time Frame: Baseline & 2 weeks
Reported daily glucose measures from baseline to two week after injection
Baseline & 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in patient reported outcomes
Time Frame: Baseline, 2 weeks, 6 weeks, 3 months
Results of patient reported outcomes via WORC scores
Baseline, 2 weeks, 6 weeks, 3 months
Change in patient reported outcomes
Time Frame: Baseline, 2 weeks, 6 weeks, 3 months
Results of patient reported outcomes via ASES scores
Baseline, 2 weeks, 6 weeks, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Anthony Ceraulo, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2023

Primary Completion (Estimated)

October 11, 2024

Study Completion (Estimated)

October 25, 2024

Study Registration Dates

First Submitted

September 8, 2021

First Submitted That Met QC Criteria

September 16, 2021

First Posted (Actual)

September 17, 2021

Study Record Updates

Last Update Posted (Actual)

December 21, 2023

Last Update Submitted That Met QC Criteria

December 15, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00108093

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus

Clinical Trials on Kenalog 40 MG

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe