Knee Steroid Injection and Blood Sugar Signatur

NCT04317404 | Completed FDA Drug

• 1 other identifier: STU 2019-1202
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Post-injection glucose levels

  Blood glucose levels after injection of steroid to the knee

  1 week

Secondary Outcomes (2)

• Post-injection adverse events

  1 week

• KOOS Knee survey

  2 weeks

Study Arms (3)

Diabetic with Knee Osteoarthritis

HbA1c between 6.5% - 12.0% in the 3 months prior to Visit 1

Drug: 40 mg Triamcinolone acetonide

Pre-diabetic with Knee Osteoarthritis

HbA1c between 5.6% - 6.4% in the 3 months prior to Visit 1

Drug: 40 mg Triamcinolone acetonide

Non-diabetic with Knee Osteoarthritis

HbA1c \< 5.6% in the 3 months prior to Visit 1

Drug: 40 mg Triamcinolone acetonide

Interventions

40 mg Triamcinolone acetonide DRUG

Unilateral knee steroid injection

Diabetic with Knee Osteoarthritis; Non-diabetic with Knee Osteoarthritis; Pre-diabetic with Knee Osteoarthritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Knee joint osteoarthritis requiring knee joint steroid injection

You may qualify if:

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

You may not qualify if:

• Less than 18 years old
• HbA1c \> 12.0%
• steroid exposure in the 3 months prior to Visit 1
• 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

Sponsors & Collaborators

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

Study Sites (1)

Parkland Hospital

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Osteoarthritis, Knee

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 19, 2020
• First Posted: March 23, 2020
• Study Start: November 1, 2020
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)