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Completed

NCT Number: NCT04761081

Is Physical Activity, Obesity, and Ethnicity Associated With the Tethering and Migration of Pro-inflammatory Monocytes?

Being south Asian or centrally obese may be associated with an increased risk of inflammation. The investigators are seeking to investigate whether this is the case by recruiting white European and south Asian men who are lean or have central obesity. Further, the investigators wish to investigate whether physical activity influences the associations.

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Key information

Age range

18 year–60 year

Sex eligibility

Male

Study type

Observational

Primary location

National Centre for Sport and Exercise Medicine

Loughborough, LE113TU, United Kingdom

About this study

Central obesity is associated with an increased risk of cardiovascular disease. Further, south Asians have been shown to be at an increased risk of cardiovascular disease compared to white Europeans.

Cardiovascular disease is underpinned by inflammation. Evidence suggests that people with obesity have a more pro-inflammatory and pro-migratory monocyte profile compared with individuals who are lean. The excessive monocyte migration contributes to metabolic dysfunction over time, increasing the risk of chronic disease. However, there is no evidence in south Asians.

One modifiable risk factor which may be able to influence this is physical inactivity, with higher levels of physical activity being associated with reduced inflammation. However, although south Asians are more at risk of cardiovascular disease than white Europeans, evidence suggests south Asians are also less physically active than white Europeans.

The investigators are looking to recruit south Asian and white European men who are lean or have central obesity to investigate 1) is there an association between ethnicity and the tethering and migration of pro-inflammatory monocytes? 2) is there an association between central obesity and the tethering and migration of pro-inflammatory monocytes, and is there an interaction with ethnicity? 3) do higher levels of physical activity influence the tethering and migration of pro-inflammatory monocytes, and is this influenced by ethnicity or central obesity?

To investigate this, the investigators are looking to recruit south Asian and white European men who are either centrally obese or lean. The investigators require 1 blood sample and the participants to wear an activity monitor for 7 days.

Peripheral blood mononuclear cells (PBMCs) will be isolated from the whole blood sample. Then, the investigators will quantify the migratory capacity of PBMCs to a fixed chemokine gradient over time. Further, the investigators will phenotype the monocytes to indicate the characteristics of the monocytes that migrate towards the chemokine mix.

The activity monitor will quantify habitual physical activity, which will be used in the statistical analyses to investigate whether physical activity may influence the response.

It is important to investigate as it will further scientific knowledge on the underpinnings of chronic disease and enable a better understanding on the role of physical activity to potentially reduce the risk.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Non-smokers (including vaping)
  • Not currently dieting

Exclusion criteria

  • Musculoskeletal injury that has affected normal ambulation within the last month;
  • Any muscle or bone injuries that influence physical activity
  • Free from heart conditions and blood disorders
  • Weight fluctuation greater than 3kg in the previous 3 months
  • Taking anti-inflammatory medication

Treatment and study plan

Habitual physical activity assessment

Behavioral

7 days habitual physical activity via accelerometry (ActiGraph GT3x). Specifically steps per day, light physical activity (minutes per day), and moderate to vigorous physical activity (minutes per day).

Primary outcomes

  1. Concentrations of classical monocytes.

    Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.

    Determined via flow cytometry. Presented as cells/uL.

  2. Concentrations of intermediate monocytes.

    Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.

    Determined via flow cytometry. Presented as cells/uL.

  3. Concentrations of non-classical monocytes.

    Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.

    Determined via flow cytometry. Presented as cells/uL.

  4. Concentrations of CCR2+ monocytes.

    Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.

    Determined via flow cytometry. Presented as cells/uL.

  5. Concentrations of CCR2+ classical monocytes.

    Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.

    Determined via flow cytometry. Presented as cells/uL.

  6. Concentrations of CCR5+ monocytes.

    Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.

    Determined via flow cytometry. Presented as cells/uL.

  7. Number of monocytes that migrated.

    Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.

    Determined via flow cytometry. Presented as number of cells.

  8. Number of classical monocytes that migrated.

    Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.

    Determined via flow cytometry. Presented as number of cells.

  9. Number of intermediate monocytes that migrated.

    Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.

    Determined via flow cytometry. Presented as number of cells.

  10. Number of non-classical monocytes that migrated.

    Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.

    Determined via flow cytometry. Presented as number of cells.

  11. Number of CCR2+ monocytes that migrated.

    Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.

    Determined via flow cytometry. Presented as number of cells.

  12. Number of CCR2+ classical monocytes that migrated.

    Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.

    Determined via flow cytometry. Presented as number of cells.

  13. Number of CCR5+ monocytes that migrated.

    Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.

    Determined via flow cytometry. Presented as number of cells.

  14. Number of monocytes that tethered.

    Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.

    Determined via flow cytometry. Presented as number of cells.

  15. Number of classical monocytes that tethered.

    Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.

    Determined via flow cytometry. Presented as number of cells.

  16. Number of intermediate monocytes that tethered.

    Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.

    Determined via flow cytometry. Presented as number of cells.

  17. Number of non-classical monocytes that tethered.

    Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.

    Determined via flow cytometry. Presented as number of cells.

  18. Number of CCR2+ monocytes that tethered.

    Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.

    Determined via flow cytometry. Presented as number of cells.

  19. Number of CCR2+ classical monocytes that tethered.

    Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.

    Determined via flow cytometry. Presented as number of cells.

  20. Number of CCR5+ monocytes that tethered.

    Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.

    Determined via flow cytometry. Presented as number of cells.

  21. CCR2+ receptor expression.

    Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.

    Determined via flow cytometry.

  22. CCR5+ receptor expression.

    Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.

    Determined via flow cytometry.

Secondary outcomes

  1. Concentration of total cholesterol.

    Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.

    Fasted concentration of total cholesterol. Presented as mmol/L.

  2. Concentration of high-density lipoprotein cholesterol (HDL).

    Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.

    Fasted concentration of high-density lipoprotein cholesterol. Presented as mmol/L.

  3. Concentration of low-density lipoprotein cholesterol (LDL).

    Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.

    Fasted concentration of low-density lipoprotein cholesterol. Presented as mmol/L.

  4. Concentration of triacylglycerol.

    Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.

    Fasted concentration of triacylglycerol. Presented as mmol/L.

  5. Concentration of glucose.

    Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.

    Fasted concentration of glucose. Presented as mmol/L.

  6. Concentration of c-reactive protein.

    Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.

    Fasted concentration of c-reactive protein. Presented as mg/L.

  7. Concentration of interleukin-6.

    Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.

    Fasted concentration of interleukin-6. Presented as pg/mL.

  8. Concentration of non-esterified free fatty acids.

    Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.

    Fasted concentration of non-esterified free fatty acids. Presented as mmol/L.

  9. Body fat percentage.

    Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.

    Body fat percentage determined via bioelectrical impedance analysis. Presented as percentage.

  10. Lean mass.

    Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.

    Determined via bioelectrical impedance analysis. Presented in kilograms.

  11. Waist circumference

    Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.

    Waist circumference. Presented as centimetres.

  12. Systolic blood pressure.

    Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.

    Presented as mmHg.

  13. Diastolic blood pressure.

    Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.

    Presented as mmHg.

  14. Light physical activity minutes per day.

    Time frame: Over 7 days +/- the assessment day

    Time spent participating in light physical activity. Presented as minutes per day.

  15. Moderate-to-vigorous activity minutes per day.

    Time frame: Over 7 days +/- the assessment day

    Time spent participating in moderate-to-vigorous physical activity. Presented as minutes per day.

  16. Daily steps.

    Time frame: Over 7 days +/- the assessment day

    Total daily steps. Presented as steps per day.

Sponsors and collaborators

Lead sponsor

Loughborough University

Other

Registry information

Official study title

Is Physical Activity Associated With the Tethering and Migration of Pro-inflammatory Monocytes in White European and South Asian Males With and Without Central Obesity.

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Feb 18, 2021
Registry last updated
Apr 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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