Knee Steroid Injection and Blood Sugar Signatur

January 17, 2023 updated by: Reed Williams, University of Texas Southwestern Medical Center

Identifying Variables Associated With Steroid-Induced Hyperglycemia Following Intra-articular Knee Injections Among Diabetic Patients

A prospective, observational study assessing the relationship between HbA1c level and the post-injection blood glucose signature. Participants will be non-diabetic, pre-diabetic, non-insulin dependent and insulin dependent type 2 diabetic patients who will be receiving a knee steroid injection. All of them will be consented a week prior to the injection, when the CGM sensor will be applied to the back of the upper arm. This will be removed a week after the injection. KOOS survey as well as VAS will be administered. Adverse events (e.g., change in medication or hospitalization) will be monitored throughout the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

11

Contacts and Locations

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

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75235
        • Parkland Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Knee joint osteoarthritis requiring knee joint steroid injection

Description

Inclusion Criteria:

  • Patients at the Parkland Outpatient Clinic
  • Indication for unilateral knee joint steroid injection for the treatment of knee joint osteoarthritis

Exclusion Criteria:

  • Less than 18 years old
  • HbA1c > 12.0%
  • steroid exposure in the 3 months prior to Visit 1
  • 3 or more steroid injections in the preceding 12 months
  • known contraindication to steroid injection (adverse reaction or allergy, active infection, INR > 3.0)
  • lack of improvement with prior knee steroid injection
  • change in diabetic medication regimen in the last 1 month
  • significant change in diet within the last 1 month
  • current use of aspirin
  • allergy to adhesive
  • planned MRI, XR, or CT during the 2-week study period

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diabetic with Knee Osteoarthritis
HbA1c between 6.5% - 12.0% in the 3 months prior to Visit 1
Drug: 40 mg Triamcinolone acetonide
Unilateral knee steroid injection
Pre-diabetic with Knee Osteoarthritis
HbA1c between 5.6% - 6.4% in the 3 months prior to Visit 1
Drug: 40 mg Triamcinolone acetonide
Unilateral knee steroid injection
Non-diabetic with Knee Osteoarthritis
HbA1c < 5.6% in the 3 months prior to Visit 1
Drug: 40 mg Triamcinolone acetonide
Unilateral knee steroid injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-injection glucose levels
Time Frame: 1 week
Blood glucose levels after injection of steroid to the knee
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-injection adverse events
Time Frame: 1 week
Adverse events after injection of steroid to the knee
1 week
KOOS Knee survey
Time Frame: 2 weeks
KOOS Knee survey administered before and after steroid injection to the knee
2 weeks

Collaborators and Investigators

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

Sponsor

University of Texas Southwestern Medical Center

Collaborators

Foundation for Physical Medicine and Rehabilitation

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)

November 1, 2020

Primary Completion (Actual)

November 30, 2022

Study Completion (Actual)

November 30, 2022

Study Registration Dates

First Submitted

March 19, 2020

First Submitted That Met QC Criteria

March 19, 2020

First Posted (Actual)

March 23, 2020

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 17, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU 2019-1202

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

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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