Clinical trial NCT04761081: Is Physical Activity, Obesity, and Ethnicity Associated With the Tethering and Migration of Pro-inflammatory Monocytes?
Official 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Physical Activity
Central Obesity
Inflammation
Keywords: Physical activity
Central obesity
Ethnicity
Inflammation
Lead sponsor: Loughborough University
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants will be recruited from the local community using advertisements published online and across local facilities and shops.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Concentrations of classical monocytes.
timeFrame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
measure: Concentrations of intermediate monocytes.
timeFrame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
measure: Concentrations of non-classical monocytes.
timeFrame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
measure: Concentrations of CCR2+ monocytes.
timeFrame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
measure: Concentrations of CCR2+ classical monocytes.
timeFrame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
measure: Concentrations of CCR5+ monocytes.
timeFrame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
measure: Number of monocytes that migrated.
timeFrame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
measure: Number of classical monocytes that migrated.
timeFrame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
measure: Number of intermediate monocytes that migrated.
timeFrame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
measure: Number of non-classical monocytes that migrated.
timeFrame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
measure: Number of CCR2+ monocytes that migrated.
timeFrame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
measure: Number of CCR2+ classical monocytes that migrated.
timeFrame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
measure: Number of CCR5+ monocytes that migrated.
timeFrame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
measure: Number of monocytes that tethered.
timeFrame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
measure: Number of classical monocytes that tethered.
timeFrame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
measure: Number of intermediate monocytes that tethered.
timeFrame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
measure: Number of non-classical monocytes that tethered.
timeFrame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
measure: Number of CCR2+ monocytes that tethered.
timeFrame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
measure: Number of CCR2+ classical monocytes that tethered.
timeFrame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
measure: Number of CCR5+ monocytes that tethered.
timeFrame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
measure: CCR2+ receptor expression.
timeFrame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
measure: CCR5+ receptor expression.
timeFrame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Secondary outcomes:
measure: Concentration of total cholesterol.
timeFrame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
measure: Concentration of high-density lipoprotein cholesterol (HDL).
timeFrame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
measure: Concentration of low-density lipoprotein cholesterol (LDL).
timeFrame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
measure: Concentration of triacylglycerol.
timeFrame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
measure: Concentration of glucose.
timeFrame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
measure: Concentration of c-reactive protein.
timeFrame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
measure: Concentration of interleukin-6.
timeFrame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
measure: Concentration of non-esterified free fatty acids.
timeFrame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
measure: Body fat percentage.
timeFrame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
measure: Lean mass.
timeFrame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
measure: Waist circumference
timeFrame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
measure: Systolic blood pressure.
timeFrame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
measure: Diastolic blood pressure.
timeFrame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
measure: Light physical activity minutes per day.
timeFrame: Over 7 days +/- the assessment day
measure: Moderate-to-vigorous activity minutes per day.
timeFrame: Over 7 days +/- the assessment day
measure: Daily steps.
timeFrame: Over 7 days +/- the assessment day
Other outcomes:
Locations:
city: Loughborough
country: United Kingdom
facility: National Centre for Sport and Exercise Medicine
Study officials:
affiliation: Loughborough University
name: Nicolette Bishop
role: PRINCIPAL_INVESTIGATOR
References: