Status:
NOT_YET_RECRUITING
Functional Investigation of Endothelial Function and Regenerative Cell Exhaustion
Lead Sponsor:
Canadian Medical and Surgical Knowledge Translation Research Group
Collaborating Sponsors:
Unity Health Toronto
University of Western Ontario, Canada
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Brief Summary
FIERCE is an observational cross-sectional study. Approximately 90 individuals living with type 2 diabetes (T2D) and/or individuals living without diabetes will be randomized (2:1). The primary objec...
Detailed Description
Type 2 diabetes (T2D) is a significant and prevalent global health concern. Individuals diagnosed with T2D are at an elevated risk of developing atherosclerotic cardiovascular (CV) disease, a leading ...
Eligibility Criteria
Inclusion
- Adults ≥18 years of age.
- Willing to provide written informed consent.
- Documented history of T2D
- No documented history of diabetes
Exclusion
- Unable or unwilling to provide written informed consent or provide a peripheral blood sample.
- Any life-threatening disease expected to result in death within two years of consent.
- Any malignancy not considered cured (except basal cell carcinoma of the skin). An individual is considered cured if there has been no evidence of cancer recurrence for the five years prior to screening.
- Known severe liver disease.
- White blood cell count ≥15 x 10\^9/L.
- Active infectious disease requiring systemic antibiotic or anti-viral agents.
- Known acquired immunodeficiency syndrome such as HIV.
- Treated autoimmune disorders (e.g. T1D and LADA).
- On oral steroid therapy (e.g. prednisone or other corticosteroids) or other immunosuppressive agents (e.g. methotrexate).
Key Trial Info
Start Date :
November 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06108388
Start Date
November 1 2023
End Date
June 1 2026
Last Update
November 13 2023
Active Locations (1)
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1
Diagnostic Assessment Centre
Scarborough Village, Ontario, Canada, M1S4N6