Knee Steroid Injection and Blood Sugar Signatur

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04317404
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Texas Southwestern Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOther
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Diabetes, Knee Osteoarthritis
Arms & Interventions

Arms

: Diabetic with Knee Osteoarthritis

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

: Pre-diabetic with Knee Osteoarthritis

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

: Non-diabetic with Knee Osteoarthritis

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

Interventions

Drug: - 40 mg Triamcinolone acetonide

Unilateral knee steroid injection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Parkland Hospital, Dallas, Texas

Status

Address

Parkland Hospital

Dallas, Texas, 75235