Knee Steroid Injection and Blood Sugar Signatur

NCT ID: NCT04317404

Last Updated: 2023-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-01

Study Completion Date

2022-11-30

Brief Summary

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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

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Conditions

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Diabetes Knee Osteoarthritis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Diabetic with Knee Osteoarthritis

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

40 mg Triamcinolone acetonide

Intervention Type DRUG

Unilateral knee steroid injection

Pre-diabetic with Knee Osteoarthritis

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

40 mg Triamcinolone acetonide

Intervention Type DRUG

Unilateral knee steroid injection

Non-diabetic with Knee Osteoarthritis

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

40 mg Triamcinolone acetonide

Intervention Type DRUG

Unilateral knee steroid injection

Interventions

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40 mg Triamcinolone acetonide

Unilateral knee steroid injection

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Foundation for Physical Medicine and Rehabilitation

OTHER

Sponsor Role collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Reed Williams

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Parkland Hospital

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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STU 2019-1202

Identifier Type: -

Identifier Source: org_study_id

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