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

Inflammation Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04761081
• Other study ID #: 2020-1885-2140
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: February 1, 2022

Study information

• Verified date: April 2022
• Source: Loughborough University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 1, 2022
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Obesity
• Inflammation
• Obesity
• Obesity, Abdominal
• Physical Activity

Intervention

Behavioral:
• Habitual physical activity assessment
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).

Locations

Country	Name	City	State
United Kingdom	National Centre for Sport and Exercise Medicine	Loughborough

Sponsors (1)

Lead Sponsor	Collaborator
Loughborough University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentrations of classical monocytes.	Determined via flow cytometry. Presented as cells/uL.	The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Primary	Concentrations of intermediate monocytes.	Determined via flow cytometry. Presented as cells/uL.	The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Primary	Concentrations of non-classical monocytes.	Determined via flow cytometry. Presented as cells/uL.	The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Primary	Concentrations of CCR2+ monocytes.	Determined via flow cytometry. Presented as cells/uL.	The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Primary	Concentrations of CCR2+ classical monocytes.	Determined via flow cytometry. Presented as cells/uL.	The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Primary	Concentrations of CCR5+ monocytes.	Determined via flow cytometry. Presented as cells/uL.	The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Primary	Number of monocytes that migrated.	Determined via flow cytometry. Presented as number of cells.	The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Primary	Number of classical monocytes that migrated.	Determined via flow cytometry. Presented as number of cells.	The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Primary	Number of intermediate monocytes that migrated.	Determined via flow cytometry. Presented as number of cells.	The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Primary	Number of non-classical monocytes that migrated.	Determined via flow cytometry. Presented as number of cells.	The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Primary	Number of CCR2+ monocytes that migrated.	Determined via flow cytometry. Presented as number of cells.	The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Primary	Number of CCR2+ classical monocytes that migrated.	Determined via flow cytometry. Presented as number of cells.	The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Primary	Number of CCR5+ monocytes that migrated.	Determined via flow cytometry. Presented as number of cells.	The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Primary	Number of monocytes that tethered.	Determined via flow cytometry. Presented as number of cells.	The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Primary	Number of classical monocytes that tethered.	Determined via flow cytometry. Presented as number of cells.	The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Primary	Number of intermediate monocytes that tethered.	Determined via flow cytometry. Presented as number of cells.	The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Primary	Number of non-classical monocytes that tethered.	Determined via flow cytometry. Presented as number of cells.	The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Primary	Number of CCR2+ monocytes that tethered.	Determined via flow cytometry. Presented as number of cells.	The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Primary	Number of CCR2+ classical monocytes that tethered.	Determined via flow cytometry. Presented as number of cells.	The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Primary	Number of CCR5+ monocytes that tethered.	Determined via flow cytometry. Presented as number of cells.	The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Primary	CCR2+ receptor expression.	Determined via flow cytometry.	The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Primary	CCR5+ receptor expression.	Determined via flow cytometry.	The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Secondary	Concentration of total cholesterol.	Fasted concentration of total cholesterol. Presented as mmol/L.	The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Secondary	Concentration of high-density lipoprotein cholesterol (HDL).	Fasted concentration of high-density lipoprotein cholesterol. Presented as mmol/L.	The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Secondary	Concentration of low-density lipoprotein cholesterol (LDL).	Fasted concentration of low-density lipoprotein cholesterol. Presented as mmol/L.	The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Secondary	Concentration of triacylglycerol.	Fasted concentration of triacylglycerol. Presented as mmol/L.	The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Secondary	Concentration of glucose.	Fasted concentration of glucose. Presented as mmol/L.	The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Secondary	Concentration of c-reactive protein.	Fasted concentration of c-reactive protein. Presented as mg/L.	The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Secondary	Concentration of interleukin-6.	Fasted concentration of interleukin-6. Presented as pg/mL.	The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Secondary	Concentration of non-esterified free fatty acids.	Fasted concentration of non-esterified free fatty acids. Presented as mmol/L.	The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Secondary	Body fat percentage.	Body fat percentage determined via bioelectrical impedance analysis. Presented as percentage.	The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Secondary	Lean mass.	Determined via bioelectrical impedance analysis. Presented in kilograms.	The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Secondary	Waist circumference	Waist circumference. Presented as centimetres.	The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Secondary	Systolic blood pressure.	Presented as mmHg.	The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Secondary	Diastolic blood pressure.	Presented as mmHg.	The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Secondary	Light physical activity minutes per day.	Time spent participating in light physical activity. Presented as minutes per day.	Over 7 days +/- the assessment day
Secondary	Moderate-to-vigorous activity minutes per day.	Time spent participating in moderate-to-vigorous physical activity. Presented as minutes per day.	Over 7 days +/- the assessment day
Secondary	Daily steps.	Total daily steps. Presented as steps per day.	Over 7 days +/- the assessment day