Not Yet RecruitingNot Applicable

Functional Investigation of Endothelial Function and Regenerative Cell Exhaustion

Canada90 participantsStarted 2023-11

Plain-language 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 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults ≥18 years of age. * Willing to provide written informed consent. * Documented history of T2D * No documented history of diabetes Exclusion Criteria: * 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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Hematopoietic colony formation in ALDHhiSSClow regenerative cell subsets

Timeframe: Baseline

Trial details

NCT IDNCT06108388

SponsorCanadian Medical and Surgical Knowledge Translation Research Group

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12

Contact for this trial

Fallon Dennis, BMSc

7057720021 fallon.dennis@mail.utoronto.ca

View on ClinicalTrials.gov More Diabetes Mellitus, Type 2 trials