Circulating Vascular Regenerative Cell Exhaustion in Individuals Without Type 2 Diabetes Who Are of South Asian or European Origins (ORIGINS-VRCE-2)

November 28, 2025 updated by: Canadian Medical and Surgical Knowledge Translation Research Group
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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Cardiovascular diseases (CVD) are the main cause of death worldwide. Notably, individuals of South Asian (SA) origin have 3 to 5-fold increased rates of CVD compared to European individuals, which cannot be entirely explained by diet, lifestyle, or socioeconomic factors. Therefore, the mechanisms driving the increased CVD risk in SA individuals remains largely unknown.

Cardiovascular health is maintained by vascular regenerative cells, which secrete pro-vascular cytokines involved in various pro-angiogenic, arteriogenic and vasculogenic pathways. It has been shown that SA adults with type 2 diabetes or CVD show vascular regenerative cell exhaustion (VRCE), characterized by a reduced number or dysfunction of pro-vascular cells compared to European adults with type 2 diabetes or CVD. Thus, VRCE presents as a novel mechanism to explain the increased cardiovascular risk SA individuals experience. However, it is unclear whether VRCE only occurs in people with cardiometabolic diseases, or if it is a phenomenon that is also present in healthy SA individuals.

ORIGINS-VRCE-2 is an observational, two-armed, cross-sectional study that will enroll 60 healthy South Asian and 60 healthy European individuals. Vascular regenerative cells will be isolated from peripheral blood samples for enumeration and characterization.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Markham, Ontario, Canada, L3S 0A2
        • Recruiting
        • Markham HealthPlex Medical Centre
        • Contact:
      • North York, Ontario, Canada, M6B 3H7
        • Not yet recruiting
        • North York Diagnostic and Cardiac Centre
        • Contact:
      • North York, Ontario, Canada, M6B4B8
        • Recruiting
        • Marlee Medical Centre
        • Contact:
      • Scarborough Village, Ontario, Canada, M1S4N6
        • Not yet recruiting
        • Diagnostic Assessment Centre
        • Contact:
      • Woodbridge, Ontario, Canada, L4L 0K8
        • Recruiting
        • Langstaff Medical Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  1. 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.
  2. Willing and able to provide written informed consent and comply with study requirements
  3. Must fulfill the following exclusion criteria:

Exclusion Criteria:

  1. No previous diagnosis of type 2 diabetes

  2. Any previous CV events such as:

    1. Prior myocardial infarction
    2. Coronary revascularization
    3. Coronary artery disease, peripheral artery disease, cerebrovascular disease
  3. Any life-threatening disease expected to result in death within the next 2 years
  4. 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
  5. Known severe liver disease (e.g. Non-alcoholic fatty liver disease, chronic liver disease, liver cirrhosis, etc.)
  6. White blood cell count ≥ 15 x 10^9/L
  7. Active infectious disease requiring antibiotic or anti-viral agents
  8. Known acquired immunodeficiency syndrome such as HIV
  9. On oral steroid therapy (e.g. prednisone) or other immunosuppressive agents (e.g. methotrexate)
  10. Treated autoimmune disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
South Asian Origins
Individuals who identify as having 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 origin
European Origins
Individuals who identify as having western European, northern European, southern European, eastern European or other European origin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Baseline

Other Outcome Measures

Outcome Measure
Time Frame
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
Baseline
Difference in the levels of inflammatory and oxidative stress biomarkers in individuals of South Asian origins and European origins
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Canadian Medical and Surgical Knowledge Translation Research Group

Collaborators

Unity Health Toronto
Western University, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2025

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

January 7, 2025

First Submitted That Met QC Criteria

January 7, 2025

First Posted (Actual)

January 10, 2025

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

November 28, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00083605

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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