Circulating Vascular Regenerative Cell Exhaustion in Individuals Without Type 2 Diabetes Who Are of South Asian or European Origins

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

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Must fulfill the following

Disqualifiers

No previous diagnosis of type 2 diabetes

Prior myocardial infarction

Coronary revascularization

Coronary artery disease, peripheral artery disease, cerebrovascular disease

Trial population

Participants will be identified from primary care and cardiology outpatient clinics in the Greater Toronto Area using paper-based and electronic medical records.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

120 Participants
are grouped into 2 trial groups
Group A: South Asian Origins
Group B: European Origins

Trial outcomes

Primary outcomes

1

The differences in the frequency / absolute number of circulating ALDHhi primitive progenitor cells co-expressing CD133 between individuals of South Asian origins and European origins

Time frame
Baseline

Secondary outcomes

1

The differences in the frequency / absolute number of circulating ALDHhiSSCmid precursor cells with monocytes/macrophage phenotype between individuals of South Asian origins and European origin

Time frame
Baseline

Other outcomes

1

Difference in the amount of intracellular reactive oxygen species (ROS) production in ALDHhi progenitor cell subsets in individuals of South Asian origins and European origins

Time frame
Baseline
2

Difference in the levels of inflammatory and oxidative stress biomarkers in individuals of South Asian origins and European origins

Time frame
Baseline

Sponsors and contacts

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Canadian Medical and Surgical Knowledge Translation Research Group

Lead sponsor

Unity Health Toronto

Collaborator

Western University, Canada

Collaborator