- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
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
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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-
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Loughborough, Spojené království, LE113TU
- National Centre for Sport and Exercise Medicine
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
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
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
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Nicolette Bishop, Loughborough University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
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Popis plánu IPD
Časový rámec sdílení IPD
Kritéria přístupu pro sdílení IPD
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