RecruitingNCT06769347
Circulating Vascular Regenerative Cell Exhaustion in Individuals Without Type 2 Diabetes Who Are of South Asian or European Origins
Sponsor
Canadian Medical and Surgical Knowledge Translation Research Group
Enrollment
120 participants
Start Date
Jan 30, 2025
Study Type
OBSERVATIONAL
Conditions
Summary
ORIGINS-VRCE-2 is an observational study aimed to assess how blood vessel forming stem cells from individuals without diabetes or a history of cardiovascular disease differ between individuals of South Asian and European ethnicities. The overarching objective of the study is to investigate whether differential vessel reparative stem cell populations and characteristics may underlie the elevated cardiovascular risk observed among South Asian individuals compared to individuals of European origins.
Eligibility
Min Age: 18 Years
Inclusion Criteria2
- Adults 18 years of age or older of South Asian origin or European origin as defined by the following: i. South Asian defined as any individual who identifies as Anglo-Indian, Bangladeshi, Bengali, Bhutanese, Goan, Gujarati, Indian, Jatt, Kashmiri, Maharashtrian, Malayali, Nepali, Pakistani, Punjabi, Sindhi, Sinhalese, Sri Lankan, Tamil, Telugu, or other South Asian origins. ii. European Origin defined as any individual who identifies as from western Europe, northern Europe, southern Europe, eastern Europe or other European origins.
- Willing and able to provide written informed consent and comply with study requirements
Exclusion Criteria13
- No previous diagnosis of type 2 diabetes
- Any previous CV events such as:
- Prior myocardial infarction
- Coronary revascularization
- Coronary artery disease, peripheral artery disease, cerebrovascular disease
- Any life-threatening disease expected to result in death within the next 2 years
- Any malignancy not considered cured (except basal cell carcinoma of the skin). A subject is considered cured if there has been no evidence of cancer recurrence for the 5 years prior to screening
- Known severe liver disease (e.g. Non-alcoholic fatty liver disease, chronic liver disease, liver cirrhosis, etc.)
- White blood cell count ≥ 15 x 10\^9/L
- Active infectious disease requiring antibiotic or anti-viral agents
- Known acquired immunodeficiency syndrome such as HIV
- On oral steroid therapy (e.g. prednisone) or other immunosuppressive agents (e.g. methotrexate)
- Treated autoimmune disorder
Locations(5)
View Full Details on ClinicalTrials.gov
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NCT06769347