Diabetes Mellitus, Type 2 Clinical Trial
— FIERCEOfficial title:
Functional Investigation of Endothelial Function and Regenerative Cell Exhaustion in Type 2 Diabetes
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.
Status | Not yet recruiting |
Enrollment | 90 |
Est. completion date | June 2026 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Canada | Diagnostic Assessment Centre | Scarborough | Ontario |
Lead Sponsor | Collaborator |
---|---|
Canadian Medical and Surgical Knowledge Translation Research Group | Unity Health Toronto, University of Western Ontario, Canada |
Canada,
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* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline | |
Secondary | 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. | Baseline | |
Secondary | 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 | Baseline |
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