Knee Steroid Injection and Blood Sugar Signatur

Completed

• Conditions: Diabetes; Knee Osteoarthritis
• Interventions: Drug: 40 mg Triamcinolone acetonide

• Registration Number: NCT04317404
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-19
• Study First Submitted QC: 2020-03-19
• Study First Posted: 2020-03-23
• Study Start: 2020-11-01
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-17
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pre-diabetic with Knee Osteoarthritis	40 mg Triamcinolone acetonide	HbA1c between 5.6% - 6.4% in the 3 months prior to Visit 1
Diabetic with Knee Osteoarthritis	40 mg Triamcinolone acetonide	HbA1c between 6.5% - 12.0% in the 3 months prior to Visit 1
Non-diabetic with Knee Osteoarthritis	40 mg Triamcinolone acetonide	HbA1c \< 5.6% in the 3 months prior to Visit 1

Primary Outcome Measures

Name	Time	Method
Post-injection glucose levels	1 week	Blood glucose levels after injection of steroid to the knee

Secondary Outcome Measures

Name	Time	Method
KOOS Knee survey	2 weeks	KOOS Knee survey administered before and after steroid injection to the knee
Post-injection adverse events	1 week	Adverse events after injection of steroid to the knee

Trial Locations

Locations (1)

Parkland Hospital; 🇺🇸 Dallas, Texas, United States