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临床试验/NCT02416843
NCT02416843已完成不适用

Metabolic and Immune System Responses to a Mixed Meal in Human Adipose Tissue and the Circulation

University of Bath2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Changes in IL6 mRNA expression in adipose tissue

研究概览

简要总结

Overweight and obesity are major problems and their complications such as cardiovascular disease and type 2 diabetes mellitus pose great burdens on healthcare systems. There is accumulating evidence to support obesity being a chronic inflammatory disorder mediated in part by the expansion of adipose (fat) tissue.

Knowledge of the role of adipose tissue itself has changed dramatically and it has emerged that in addition to storing energy as fats; adipose tissue secretes and responds to various chemical messengers in the body that are related to metabolism and inflammation. After a meal has been consumed, changes in metabolic (and some inflammatory) markers are seen in the blood, which may be influenced by metabolic and inflammatory changes occuring in the adipose tissue itself.

The investigators therefore plan to investigate these changes in adipose tissue before and after a meal and compare them to changes occurring in the blood. They also plan to investigate whether these responses are different in people who are overweight compared to 'normal' weight.

Participants will include males aged between 35-55 years who fit the criteria for inclusion. After taking some preliminary measurements and monitoring of normal daily activities, participants will attend one day of Laboratory testing in the Physiology Laboratories at the University of Bath.

By investigating differences in metabolism and inflammation in adipose tissue and the circulation it is hoped that more will be learnt about the development of diseases associated with being overweight and ultimately help to develop more effective methods for prevention and treatment.

详细描述

The aim of this research is to investigate differences in metabolism and inflammation in adipose tissue and the circulation in response to a meal with increasing adiposity. It is hypothesised that participants with increased fat mass, will have a more pronounced inflammatory response to a meal compared to participants with a 'healthy' weight. The inflammatory response will be assessed by measuring changes in gene expression and protein secretion in the adipose tissue and by measuring markers of metabolism, insulin resistance, cardiovascular disease and inflammation in the blood.

Following advertisement of the study, interested potential participants will be asked to contact the Chief Investigator for further information via email/telephone correspondence. There will be an initial assessment of eligibility based on inclusion/exclusion criteria and, if these requirements are met, the potential participant will be invited to a meeting to further discuss the trial. After they have read the participant information sheet and seen the flowchart outlining the timeline for the study, if they would like to take part, they will be asked to sign a consent form. Dates will then be scheduled for some preliminary anthropometric measurements to be taken, 9 days of physical activity monitoring and the trial date (1 full day in the laboratory only).

Preliminary measurements:

Preliminary testing will include anthropometric measurements of height, weight, waist and hip circumferences, sagittal waist height and blood pressure. These measurements will take place at the University of Bath Physiology Laboratories.

Physical activity monitoring:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
35 Years 至 55 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Subjects should be:
  • Nonsmokers
  • Weight stable for more than 3 months

排除标准

  • Subjects should not :
  • have a personal history of/existing cardiovascular disease, metabolic disease or dyslipidaemia
  • be taking medications that may influence lipid or carbohydrate metabolism
  • have food intolerances/allergies to any component of the meal (i.e. dairy or wheat)
  • Perform no more than 6 hours of strenuous physical activity or 10 hours of moderate intensity physical activity per week (as these individuals will not fit the meal standardisation procedure)

结局指标

主要结局

Changes in IL6 mRNA expression in adipose tissue

时间窗: 6 hours

mRNA expression of IL6 will be measured in adipose tissue samples obtained pre and 6 hours post consumption of the mixed meal to assess for postprandial inflammatory changes in adipose tissue.

次要结局

  • Changes in IL-6 secretion by adipose tissue(6 hours)
  • Characterisation of immune cell populations in adipose tissue(6 hours)
  • Analysis of insulin stimulated pathways(6 hours)
  • Effect of adipocytes on T Lymphocyte activation(6 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rebecca Travers

PhD Student

University of Bath

研究点 (2)

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