- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04761081
Is Physical Activity, Obesity, and Ethnicity Associated With the Tethering and Migration of Pro-inflammatory Monocytes?
Is Physical Activity Associated With the Tethering and Migration of Pro-inflammatory Monocytes in White European and South Asian Males With and Without Central Obesity.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
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
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Loughborough, Reino Unido, LE113TU
- National Centre for Sport and Exercise Medicine
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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
¿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
Patrocinador
Investigadores
- Investigador principal: Nicolette Bishop, Loughborough University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2020-1885-2140
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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