Functional Investigation of Endothelial Function and Regenerative Cell Exhaustion

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCanadian Medical and Surgical Knowledge Translation Research Group

About this trial

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.

Eligibility criteria

Qualifiers

Adults ≥18 years of age.

Willing to provide written informed consent.

Documented history of T2D

No documented history of diabetes

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

90 Participants
are grouped into 2 trial groups

Sponsors and collaborators

Canadian Medical and Surgical Knowledge Translation Research Group

Lead sponsor

Unity Health Toronto

Collaborator

University of Western Ontario, Canada

Collaborator