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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
-
Loughborough, Reino Unido, LE113TU
- National Centre for Sport and Exercise Medicine
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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).
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Concentrations of classical monocytes.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Concentration of total cholesterol.
Prazo: 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).
Prazo: 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).
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2020-1885-2140
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .