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

7. dubna 2022 aktualizováno: Nicolette Bishop, Loughborough University

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.

Přehled studie

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Aktuální)

40

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

      • Loughborough, Spojené království, LE113TU
        • National Centre for Sport and Exercise Medicine

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 60 let (Dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Mužský

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

All participants will be recruited from the local community using advertisements published online and across local facilities and shops.

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
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.

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).
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.

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).
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.

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).
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.

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).

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Concentrations of classical monocytes.
Časové okno: 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.
The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Concentrations of intermediate monocytes.
Časové okno: 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.
The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Concentrations of non-classical monocytes.
Časové okno: 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.
The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Concentrations of CCR2+ monocytes.
Časové okno: 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.
The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Concentrations of CCR2+ classical monocytes.
Časové okno: 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.
The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Concentrations of CCR5+ monocytes.
Časové okno: 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.
The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Number of monocytes that migrated.
Časové okno: 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.
The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Number of classical monocytes that migrated.
Časové okno: 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.
The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Number of intermediate monocytes that migrated.
Časové okno: 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.
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.
Časové okno: 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.
The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Number of CCR2+ monocytes that migrated.
Časové okno: 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.
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.
Časové okno: 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.
The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Number of CCR5+ monocytes that migrated.
Časové okno: 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.
The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Number of monocytes that tethered.
Časové okno: 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.
The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Number of classical monocytes that tethered.
Časové okno: 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.
The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Number of intermediate monocytes that tethered.
Časové okno: 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.
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.
Časové okno: 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.
The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Number of CCR2+ monocytes that tethered.
Časové okno: 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.
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.
Časové okno: 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.
The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Number of CCR5+ monocytes that tethered.
Časové okno: 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.
The outcome will be measured as a single-time point assessment in a fasted state on day 1.
CCR2+ receptor expression.
Časové okno: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
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.
Časové okno: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Determined via flow cytometry.
The outcome will be measured as a single-time point assessment in a fasted state on day 1.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Concentration of total cholesterol.
Časové okno: 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.
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).
Časové okno: 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.
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).
Časové okno: 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.
The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Concentration of triacylglycerol.
Časové okno: 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.
The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Concentration of glucose.
Časové okno: 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.
The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Concentration of c-reactive protein.
Časové okno: 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.
The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Concentration of interleukin-6.
Časové okno: 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.
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.
Časové okno: 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.
The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Body fat percentage.
Časové okno: 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.
The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Lean mass.
Časové okno: 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.
The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Waist circumference
Časové okno: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Waist circumference. Presented as centimetres.
The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Systolic blood pressure.
Časové okno: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Presented as mmHg.
The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Diastolic blood pressure.
Časové okno: The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Presented as mmHg.
The outcome will be measured as a single-time point assessment in a fasted state on day 1.
Light physical activity minutes per day.
Časové okno: Over 7 days +/- the assessment day
Time spent participating in light physical activity. Presented as minutes per day.
Over 7 days +/- the assessment day
Moderate-to-vigorous activity minutes per day.
Časové okno: Over 7 days +/- the assessment day
Time spent participating in moderate-to-vigorous physical activity. Presented as minutes per day.
Over 7 days +/- the assessment day
Daily steps.
Časové okno: Over 7 days +/- the assessment day
Total daily steps. Presented as steps per day.
Over 7 days +/- the assessment day

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Nicolette Bishop, Loughborough University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. března 2021

Primární dokončení (Aktuální)

1. srpna 2021

Dokončení studie (Aktuální)

1. února 2022

Termíny zápisu do studia

První předloženo

9. února 2021

První předloženo, které splnilo kritéria kontroly kvality

16. února 2021

První zveřejněno (Aktuální)

18. února 2021

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

8. dubna 2022

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

7. dubna 2022

Naposledy ověřeno

1. dubna 2022

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • 2020-1885-2140

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

Anonymised individual participant data for all primary and secondary outcome measures will be made upon request.

Časový rámec sdílení IPD

The data will be available 6 months after publication for 12 months.

Kritéria přístupu pro sdílení IPD

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.

Informace o lécích a zařízeních, studijní dokumenty

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Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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