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Studies

Interventional Recruiting

NCT05829018 on ClinicalTrials.gov

Elucidating the High Cardiovascular Disease Risk in South Asians

Official title: Elucidating the High Cardiovascular Disease Risk in South Asians: Focus on Monocyte Phenotype and Incretin Hormones

  • Sponsor: Leiden University Medical Center
  • Enrollment: 48 (Estimated)
  • Study start: 2023-04-01 (Estimated)
  • Primary completion: 2024-03-01 (Estimated)
  • Study completion: 2024-06-01 (Estimated)
  • Allocation: Non-Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: Cross-sectional study
  • Masking: Single (Participant)
  • PrimaryPurpose: Basic Science

Brief Summary

The goals of this cross-sectional study are to compare immune cell composition and release of incretin hormones following a meal in healthy Dutch South Asians and Dutch Europids. The primary aim is to assess potential differences between Dutch South Asians and Dutch Europids with respect to immune cell composition and monocyte phenotype.

The secondary aim is to assess potential differences between Dutch South Asians and Dutch Europids with respect to hunger and satiety hormones following a mixed meal test.

The investigators will include healthy lean male and female participants of Dutch South Asian and Dutch Europid descent (n=48 in total).

Conditions

  • Cardiovascular Diseases

Intervention / Treatment

  • Diagnostic Test: Mixed meal test

Primary Outcome Measures

  • Immune cell composition (Baseline)
    Differences in immune cell composition via flow cytometry in Dutch South Asians and Dutch Europids, via the measurement of CD14, CD16, HLA-DR (monocytes), CD3, CD4, CD8, CD46 and CD19
  • Monocyte phenotype (Baseline)
    Differences in the monocyte phenotype via the measurements of monocyte subset percentage and their expression of key proteins, including inflammatory and anti-inflammatory markers and receptors via flow cytometry of fresh blood samples in Dutch South Asians and Dutch Europids. After red blood cell lysis, immune cells will be stained by a range of monocyte/immune/activation markers (e.g. CD14, CD16, CD80, CD86, HLA-DR, CCR2, CD11c, CD36, CX3CR1, CD45RA, CD206, CD200R), fixed and stored at 4°C for follow-up fluorescence-activated cell sorting (FACS).
  • Functional and Metabolic characteristics of monocytes (Baseline)
    Difference in functional and metabolic characteristics of monocytes via in vitro stimulation with lipopolysaccharides, GLP-1 and GIP and Seahorse measurements in Dutch South Asians and Dutch Europids Whole blood will be activated in cell culture dishes in vitro with the prototypical pro-inflammatory Toll-like Receptor 4 trigger LPS with/without preincubation with GLP-1 and/or GIP and supernatant will be collected and stored at -80°C. Once samples from all donors are collected, the production of cytokines will be assessed (i.e. IL-6, TNF-α, IL-12p70, IL-8) by Enzyme-Linked Immune Sorbent Assay

Countries

Netherlands

Locations and Investigators

  • Leiden University Medical Center, Leiden, Netherlands (Recruiting)
    • Mariëtte R Boon, MD PhD

Study Officials