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 objective of this trial is to determine if there are differences in the content and function of circulating vascular regenerative (VR) progenitor cell subsets isolated from individuals living with T2D versus individuals not living with T2D. The main question this study aims to answer is: Does T2D compromise or enhance VR cell functionality?
Each participant will be asked to provide a single blood sample. Blood samples will be processed to enumerate the number of vessel-repairing cells and determine the functionality of the different subtypes of vessel-repairing cells.
Adults ≥18 years of age.
Willing to provide written informed consent.
Documented history of T2D
No documented history of diabetes
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.
Participants will be identified from primary care clinics in the Greater Toronto Area using paper-based and electronic medical records.
Case-control
Cross-sectional
Not listed
Hematopoietic colony formation in ALDHhiSSClow regenerative cell subsets
The capacity for total multipotent hematopoietic colony formation in ALDHhiSSClow regenerative cell subsets isolated from individuals living with T2D versus individuals not living with T2D.
Endothelial function
Endothelial peripheral arterial tonometry (EndoPAT) will be utilized to clinically analyze endothelial function through reactive hyperemic index in individuals living with T2D and individuals not living with T2D.
Frequency and absolute number of circulating ALDHhiSSClowCD133+ progenitor cells
The change in the frequency and absolute number of circulating ALDHhiSSClowCD133+ progenitor cells between individuals living with T2D versus age- and sex-matched individuals not living with T2D
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Canadian Medical and Surgical Knowledge Translation Research Group
Lead sponsor
Unity Health Toronto
Collaborator
University of Western Ontario, Canada
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
