Physical ActivityNCT04761081
Is Physical Activity, Obesity, and Ethnicity Associated With the Tethering and Migration of Pro-inflammatory Monocytes?
An observational study of Physical Activity and Central Obesity, run by Loughborough University at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Central Obesity, Inflammation
- What is being tested?
- Habitual physical activity assessment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2021to 1 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: All participants will be recruited from the local community using advertisements published online and across local facilities and shops.
Who may be able to join
- Non-smokers (including vaping)
- Not currently dieting
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
National Centre for Sport and Exercise Medicine
Loughborough, LE113TU
About this study
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.
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.
Read the 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.
- Conditions
- Physical Activity, Central Obesity, Inflammation
- Being tested
- Habitual physical activity assessment
- Keywords
- Physical activity, Central obesity, Ethnicity, Inflammation
- Medical subject headings
- Motor Activity, Obesity, Abdominal, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Habitual physical activity assessmentBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Habitual physical activity assessment | |
| 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. Receives: Behavioral: Habitual physical activity assessment | |
| 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. Receives: Behavioral: Habitual physical activity assessment | |
| 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. Receives: Behavioral: Habitual physical activity assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentrations of classical monocytes.
Determined via flow cytometry. Presented as cells/uL.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Fasted concentration of total cholesterol. Presented as mmol/L.
Measured: 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).
Fasted concentration of high-density lipoprotein cholesterol. Presented as mmol/L.
Measured: 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).
Fasted concentration of low-density lipoprotein cholesterol. Presented as mmol/L.
Measured: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Concentration of triacylglycerol.
Fasted concentration of triacylglycerol. Presented as mmol/L.
Measured: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Concentration of glucose.
Fasted concentration of glucose. Presented as mmol/L.
Measured: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Concentration of c-reactive protein.
Fasted concentration of c-reactive protein. Presented as mg/L.
Measured: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Concentration of interleukin-6.
Fasted concentration of interleukin-6. Presented as pg/mL.
Measured: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Concentration of non-esterified free fatty acids.
Fasted concentration of non-esterified free fatty acids. Presented as mmol/L.
Measured: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Body fat percentage.
Body fat percentage determined via bioelectrical impedance analysis. Presented as percentage.
Measured: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Lean mass.
Determined via bioelectrical impedance analysis. Presented in kilograms.
Measured: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Waist circumference
Waist circumference. Presented as centimetres.
Measured: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Systolic blood pressure.
Presented as mmHg.
Measured: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Diastolic blood pressure.
Presented as mmHg.
Measured: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Light physical activity minutes per day.
Time spent participating in light physical activity. Presented as minutes per day.
Measured: Over 7 days +/- the assessment day
Moderate-to-vigorous activity minutes per day.
Time spent participating in moderate-to-vigorous physical activity. Presented as minutes per day.
Measured: Over 7 days +/- the assessment day
Daily steps.
Total daily steps. Presented as steps per day.
Measured: Over 7 days +/- the assessment day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Mar 2021
- Primary completion1 Aug 2021
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolette Bishop, Loughborough University
- Investigators
- Nicolette Bishop, Principal investigator, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761081
- Sponsor's protocol ID
- 2020-1885-2140
- Status last verified
- Apr 2022
- First submitted
- 9 Feb 2021
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised individual participant data for all primary and secondary outcome measures will be made upon request.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04761081
- Acronym / sponsor ID
- 2020-1885-2140
- Conditions
- Physical Activity, Central Obesity, Inflammation
- Keywords
- Physical activity, Central obesity, Ethnicity, Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| South Asians who are lean | – | Behavioral: Habitual physical activity assessmentThe 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 | – | Behavioral: Habitual physical activity assessmentThe 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 | – | Behavioral: Habitual physical activity assessmentThe 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 | – | Behavioral: Habitual physical activity assessmentThe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All participants will be recruited from the local community using advertisements published online and across local facilities and shops.
Key inclusion criteria (2 listed)
- Non-smokers (including vaping)
- Not currently dieting
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Habitual physical activity assessment7 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). | Behavioural | South Asians who are lean, South Asians with central obesity, White Europeans who are lean, White Europeans with central obesity |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
16 secondary outcomes
Concentration of total cholesterol.
Time frame: 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).
Time frame: 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).
Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Concentration of triacylglycerol.
Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Concentration of glucose.
Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
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.
Concentration of interleukin-6.
Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
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.
Body fat percentage.
Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Lean mass.
Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Waist circumference
Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Systolic blood pressure.
Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Diastolic blood pressure.
Time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Light physical activity minutes per day.
Time frame: Over 7 days +/- the assessment day
Moderate-to-vigorous activity minutes per day.
Time frame: Over 7 days +/- the assessment day
Daily steps.
Time frame: Over 7 days +/- the assessment day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Individual participant dataSharing planned: Yes. Anonymised individual participant data for all primary and secondary outcome measures will be made upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolette Bishop principal investigator
Loughborough University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Activity and Central Obesity, run by Loughborough University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentrations of classical monocytes. (time frame: The outcome will be measured as a single-time point assessment in a fasted state on day 1.). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.