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

7 de abril de 2022 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Actual)

40

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Loughborough, Reino Unido, LE113TU
        • National Centre for Sport and Exercise Medicine

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 60 años (Adulto)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Masculino

Método de muestreo

Muestra no probabilística

Población de estudio

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

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Concentrations of classical monocytes.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Concentration of total cholesterol.
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: Over 7 days +/- the assessment day
Total daily steps. Presented as steps per day.
Over 7 days +/- the assessment day

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Nicolette Bishop, Loughborough University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de marzo de 2021

Finalización primaria (Actual)

1 de agosto de 2021

Finalización del estudio (Actual)

1 de febrero de 2022

Fechas de registro del estudio

Enviado por primera vez

9 de febrero de 2021

Primero enviado que cumplió con los criterios de control de calidad

16 de febrero de 2021

Publicado por primera vez (Actual)

18 de febrero de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de abril de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

7 de abril de 2022

Última verificación

1 de abril de 2022

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 2020-1885-2140

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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

Marco de tiempo para compartir IPD

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

Criterios de acceso compartido de 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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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