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

7. april 2022 oppdatert av: 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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

40

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Loughborough, Storbritannia, LE113TU
        • National Centre for Sport and Exercise Medicine

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 60 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Mann

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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).

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Concentrations of classical monocytes.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Concentration of total cholesterol.
Tidsramme: 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).
Tidsramme: 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).
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: Over 7 days +/- the assessment day
Total daily steps. Presented as steps per day.
Over 7 days +/- the assessment day

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Nicolette Bishop, Loughborough University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mars 2021

Primær fullføring (Faktiske)

1. august 2021

Studiet fullført (Faktiske)

1. februar 2022

Datoer for studieregistrering

Først innsendt

9. februar 2021

Først innsendt som oppfylte QC-kriteriene

16. februar 2021

Først lagt ut (Faktiske)

18. februar 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. april 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. april 2022

Sist bekreftet

1. april 2022

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

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

Tilgangskriterier for IPD-deling

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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