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

2022년 4월 7일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

관찰

등록 (실제)

40

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Loughborough, 영국, LE113TU
        • National Centre for Sport and Exercise Medicine

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

남성

샘플링 방법

비확률 샘플

연구 인구

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

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
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).

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Concentrations of classical monocytes.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.

2차 결과 측정

결과 측정
측정값 설명
기간
Concentration of total cholesterol.
기간: 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).
기간: 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).
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: Over 7 days +/- the assessment day
Total daily steps. Presented as steps per day.
Over 7 days +/- the assessment day

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Nicolette Bishop, Loughborough University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2021년 3월 1일

기본 완료 (실제)

2021년 8월 1일

연구 완료 (실제)

2022년 2월 1일

연구 등록 날짜

최초 제출

2021년 2월 9일

QC 기준을 충족하는 최초 제출

2021년 2월 16일

처음 게시됨 (실제)

2021년 2월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2022년 4월 8일

QC 기준을 충족하는 마지막 업데이트 제출

2022년 4월 7일

마지막으로 확인됨

2022년 4월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 2020-1885-2140

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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

IPD 공유 기간

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

IPD 공유 액세스 기준

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.

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미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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