Knee Steroid Injection and Blood Sugar Signatur

• Sponsor: University of Texas Southwestern Medical Center (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04317404
• Collaborator: Foundation for Physical Medicine and Rehabilitation (Other)
• Enrollment: 45
• Location: 1
• Anticipated Duration (Months): 36.9
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes; Knee Osteoarthritis	Drug: 40 mg Triamcinolone acetonide

Study Design

• Study Type: Observational
• Anticipated Enrollment: 45 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Identifying Variables Associated With Steroid-Induced Hyperglycemia Following Intra-articular Knee Injections Among Diabetic Patients
• Actual Study Start Date: Nov 1, 2020
• Anticipated Primary Completion Date: Nov 30, 2022
• Anticipated Study Completion Date: Nov 30, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Post-injection glucose levels [1 week]

   Blood glucose levels after injection of steroid to the knee

Secondary Outcome Measures

1. Post-injection adverse events [1 week]

   Adverse events after injection of steroid to the knee

2. KOOS Knee survey [2 weeks]

   KOOS Knee survey administered before and after steroid injection to the knee

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Parkland Hospital	Dallas	Texas	United States	75235

Sponsors and Collaborators

• University of Texas Southwestern Medical Center
• Foundation for Physical Medicine and Rehabilitation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Reed Williams, Assistant Professor, University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT04317404
• Other Study ID Numbers: STU 2019-1202
• First Posted: Mar 23, 2020
• Last Update Posted: Dec 29, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate

Study Results

No Results Posted as of Dec 29, 2021