Knee Steroid Injection and Blood Sugar Signatur

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04317404
• Other study ID #: STU 2019-1202
• Status: Completed
• Start date: November 1, 2020
• Est. completion date: November 30, 2022

Study information

• Verified date: January 2023
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• 40 mg Triamcinolone acetonide
Unilateral knee steroid injection

Locations

Country	Name	City	State
United States	Parkland Hospital	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	Foundation for Physical Medicine and Rehabilitation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-injection glucose levels	Blood glucose levels after injection of steroid to the knee	1 week
Secondary	Post-injection adverse events	Adverse events after injection of steroid to the knee	1 week
Secondary	KOOS Knee survey	KOOS Knee survey administered before and after steroid injection to the knee	2 weeks