Is Physical Activity, Obesity, and Ethnicity Associated With the Tethering and Migration of Pro-inflammatory Monocytes?
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.
1 other identifier
observational
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2021
CompletedFirst Posted
Study publicly available on registry
February 18, 2021
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2022
CompletedApril 8, 2022
April 1, 2022
5 months
February 9, 2021
April 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (22)
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 Outcomes (16)
Concentration of total cholesterol.
The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Concentration of high-density lipoprotein cholesterol (HDL).
The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Concentration of low-density lipoprotein cholesterol (LDL).
The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Concentration of triacylglycerol.
The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Concentration of glucose.
The outcome will be measured as a single-time point assessment in a fasted state on day 1.
- +11 more secondary outcomes
Study Arms (4)
South Asians who are lean
The south Asian group who are lean will be of south Asian ethnicity and a waist circumference \<90cm. The group will receive an accelerometer (Actigraph GT3x) to wear for 7 days to measure habitual physical activity. They will then provide a single blood donation in a fasted state which we will use to quantify the migration of pro-inflammatory monocytes towards adipose tissue specific media. This will then be compared to the other 3 groups to investigate the interaction between ethnicity, central obesity, and physical activity with the migration of pro-inflammatory monocytes. Metabolic markers will be analysed and presented in a participant characteristics table.
South Asians with central obesity
The south Asian group with central obesity will be of south Asian ethnicity and a waist circumference of 90cm or greater. The group will receive an accelerometer (Actigraph GT3x) to wear for 7 days to measure habitual physical activity. They will then provide a single blood donation in a fasted state which we will use to quantify the migration of pro-inflammatory monocytes towards adipose tissue specific media. This will then be compared to the other 3 groups to investigate the interaction between ethnicity, central obesity, and physical activity with the migration of pro-inflammatory monocytes. Metabolic markers will be analysed and presented in a participant characteristics table.
White Europeans who are lean
The white European group who are lean will be of white European ethnicity and a waist circumference \<94cm. The group will receive an accelerometer (Actigraph GT3x) to wear for 7 days to measure habitual physical activity. They will then provide a single blood donation in a fasted state which we will use to quantify the migration of pro-inflammatory monocytes towards adipose tissue specific media. This will then be compared to the other 3 groups to investigate the interaction between ethnicity, central obesity, and physical activity with the migration of pro-inflammatory monocytes. Metabolic markers will be analysed and presented in a participant characteristics table.
White Europeans with central obesity
The white European group with central obesity will be of white European ethnicity and a waist circumference of 94cm or greater. The group will receive an accelerometer (Actigraph GT3x) to wear for 7 days to measure habitual physical activity. They will then provide a single blood donation in a fasted state which we will use to quantify the migration of pro-inflammatory monocytes towards adipose tissue specific media. This will then be compared to the other 3 groups to investigate the interaction between ethnicity, central obesity, and physical activity with the migration of pro-inflammatory monocytes. Metabolic markers will be analysed and presented in a participant characteristics table.
Interventions
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).
Eligibility Criteria
All participants will be recruited from the local community using advertisements published online and across local facilities and shops.
You may qualify if:
- Non-smokers (including vaping)
- Not currently dieting
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Centre for Sport and Exercise Medicine
Loughborough, LE113TU, United Kingdom
Biospecimen
Plasma samples will be stored for the measurement of metabolic markers (triacylglycerol, glucose, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, non-esterified free fatty acids, c-reactive protein, interleukin-6.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicolette Bishop
Loughborough University
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 9, 2021
First Posted
February 18, 2021
Study Start
March 1, 2021
Primary Completion
August 1, 2021
Study Completion
February 1, 2022
Last Updated
April 8, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- The data will be available 6 months after publication for 12 months.
- Access Criteria
- Data will be available to other researchers who would like to run the same statistical methods we have used to check the interpretation of results.
Anonymised individual participant data for all primary and secondary outcome measures will be made upon request.