Status:
COMPLETED
The Role of South Asian vs European Origins on Circulating Regenerative Cell Exhaustion
Lead Sponsor:
Canadian Medical and Surgical Knowledge Translation Research Group
Collaborating Sponsors:
Unity Health Toronto
Western University, Canada
Conditions:
Diabetes
Type 1 Diabetes
Eligibility:
All Genders
40+ years
Brief Summary
ORIGINS-RCE is an observational, cross-sectional, two-arm study aimed at determining if an individual's ethnic origin influences the number of blood vessel-forming stem cells in the bloodstream. Circu...
Detailed Description
Individuals of South Asian origins have been reported to be at higher risk of ischemic heart disease than those of European origins. While differential morphometries and culturally related behavioural...
Eligibility Criteria
Inclusion
- Adults 40 years of age or older of South Asian origin or white European origin as defined by the following:
- 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.
- White Europeans or European Origin defined as any individual who identifies as from western European, other northern European, southern European, eastern European or other European origins.
- Willing and able to provide written informed consent and comply with study requirements.
- Must meet criteria of one of the two following groups:
- Established diabetes (HbA1c ≤10.5%) with no CVD but meets 1 or more of the following criteria:
- On insulin therapy
- Cigarette smoker or stopped smoking within 3 months
- Documented hypertension (as defined by a sitting blood pressure at screening of ≥130/80 mmHg) OR currently on antihypertensive therapy
- History of treated or untreated dyslipidemia
- High sensitivity C-reactive protein ≥2.0 mg/L
- eGFR 30 to 60 mL/min/1.73m\^2
- Documented micro- or macro-albuminuria
- Established CVD and meets 1 or more of the following criteria within 10 years prior to screening:
- Documented coronary artery disease (CAD)
- Documented cerebrovascular or carotid disease
- Documented peripheral artery disease (PAD)
- Exclusion Criteria:
- Severe congestive heart failure (as defined by New York Heart Association - class IV)
- 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
- 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 corticosteroids) or other immunosuppressive agents (e.g. methotrexate)
- Treated autoimmune disorder (excluding type 1 diabetes)
Exclusion
Key Trial Info
Start Date :
January 8 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 18 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05253521
Start Date
January 8 2022
End Date
January 18 2023
Last Update
February 9 2023
Active Locations (3)
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1
Markham HealthPlex Medical Centre
Markham, Ontario, Canada, L3S0A2
2
North York Diagnostic and Cardiac Centre
North York, Ontario, Canada, M6B1N6
3
Diagnostic Assessment Centre
Scarborough Village, Ontario, Canada, M1S4N6