- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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 studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
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Loughborough, Zjednoczone Królestwo, LE113TU
- National Centre for Sport and Exercise Medicine
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
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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).
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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).
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|
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).
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Concentrations of classical monocytes.
Ramy czasowe: 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.
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The outcome will be measured as a single-time point assessment in a fasted state on day 1.
|
|
Concentrations of intermediate monocytes.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Concentration of total cholesterol.
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: Over 7 days +/- the assessment day
|
Total daily steps.
Presented as steps per day.
|
Over 7 days +/- the assessment day
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Nicolette Bishop, Loughborough University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2020-1885-2140
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Ramy czasowe udostępniania IPD
Kryteria dostępu do udostępniania IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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