Elucidating the High Cardiovascular Disease Risk in South Asians

NCT05829018 | Unknown

• 1 other identifier: 22097
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Immune cell composition

  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

  Baseline

• Monocyte phenotype

  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).

  Baseline

• Functional and Metabolic characteristics of monocytes

  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

  Baseline

Secondary Outcomes (2)

• Incretin hormones

  Baseline, and after 10, 20, 30, 60, 90, 120, 180 and 240 minutes after the mixed meal

• Glucocorticoid receptor sensitivity

  Baseline

Study Arms (4)

Dutch South Asian males

ACTIVE COMPARATOR

males of Dutch South Asian descent, as defined as having 4 grandparents that originally descended from either Surinam, Bangladesh, India, Nepal, Pakistan, Afghanistan, Bhutan or Sri Lanka

Diagnostic Test: Mixed meal test

Dutch South Asian females

ACTIVE COMPARATOR

females of Dutch South Asian descent, as defined as having 4 grandparents that originally descended from either Surinam, Bangladesh, India, Nepal, Pakistan, Afghanistan, Bhutan or Sri Lanka

Diagnostic Test: Mixed meal test

Dutch Europid males

ACTIVE COMPARATOR

males of Europid descent, as defined as having 4 grandparents from European origin

Diagnostic Test: Mixed meal test

Dutch Europid females

ACTIVE COMPARATOR

females of Europid descent, as defined as having 4 grandparents from European origin

Diagnostic Test: Mixed meal test

Interventions

Mixed meal test DIAGNOSTIC_TEST

Nutridrink 270 mL 405 kcal, 49 Energy% carbohydrates, 35 Energy% fat, 16 Energy% protein, vitamins, and minerals

Also known as: Nutridrink, Nutricia

Dutch Europid females; Dutch Europid males; Dutch South Asian females; Dutch South Asian males

Eligibility Criteria

• Age: 18 Years - 30 Years
• Gender Eligibility Details: Biologically male and female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Biologically male and female
• South Asian or Dutch European ethnicity (South Asian ethnicity is defined as having 4 grandparents that originally descended from either Surinam, Bangladesh, India, Nepal, Pakistan, Afghanistan, Bhutan or Sri Lanka)
• Age from 18 to 30 years old
• BMI 18-23 kg/m2
• Capable of giving written informed consent
• Able to comply with the requirements and restrictions listed in the informed consent form

You may not qualify if:

• (auto-) immune disease(s) including type 1 or 2 diabetes mellitus, chronic kidney disease, hepatic disease, inflammatory bowel disease, thyroid disease and rheumatoid arthritis.
• Genetic lipid-associated disorders such as familial hypercholesterolemia
• Any chronic renal or hepatic disease
• Use of medication known to influence glucose and/or lipid metabolism (e.g. beta-blockers, antidepressants, corticosteroids)
• Abuse of alcohol or other substances
• Smoking
• Vigorous exercise (\>3 times/week)
• Milk or soy allergy

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Leiden University Medical Center

Leiden, 2333ZA, Netherlands

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Mariëtte R Boon

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariëtte R Boon, MD PhD

CONTACT

+31(0)6-48126425; m.r.boon@lumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mariëtte Boon, MD PhD, Principal Investigator

Model Details: Cross-sectional study

Study Record Dates

• First Submitted: March 18, 2023
• First Posted: April 25, 2023
• Study Start: April 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: June 1, 2024
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)