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Completed

NCT Number: NCT04317404

Knee Steroid Injection and Blood Sugar Signatur

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.

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Key information

Conditions

Diabetes Arthritis Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Joint Diseases Knee Osteoarthritis Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Parkland Hospital

Dallas, Texas, 75235, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

40 mg Triamcinolone acetonide

Drug

Unilateral knee steroid injection

Primary outcomes

  1. Post-injection glucose levels

    Time frame: 1 week

    Blood glucose levels after injection of steroid to the knee

Secondary outcomes

  1. Post-injection adverse events

    Time frame: 1 week

    Adverse events after injection of steroid to the knee

  2. KOOS Knee survey

    Time frame: 2 weeks

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

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • Foundation for Physical Medicine and Rehabilitation

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 23, 2020
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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