A Randomized Cross Over Trial About the Influence of Skin Temperature Gradient on the Variation of Metabolic Hormones in Climates With Different Ambient Air Temperatures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Change from baseline for adipokines (leptin, adiponectin and ghrelin) at day seven
研究概览
简要总结
The Cyprus International Institute for Environmental and Public Health of the Cyprus University of Technology is planning a pilot study of health indicators in relation to spatially varying climatic conditions ranging from the city to the mountainous environment. The purpose of the project is to understand the effect of fluctuations in external climatic conditions on the human body temperature and metabolic biomarkers or stress hormones.
Climate change phenomena such as protracted heat waves that create areas with even higher temperatures, especially in urban centers, may have a negative impact on human health. The effects may be acute for an individual with the appearance of discomfort and headaches, while chronic exposures to high air temperatures for the general population have been linked with premature mortality and cardiovascular diseases. Due to climate change that is hitting hard the Mediterranean, these temperature changes have been more and more common in Cyprus in recent years.
One of the usual ways of dealing with high temperatures is the use of air conditioners. With sudden and frequent temperature changes during the day, the human body is subject to thermal shock for varying duration and number of times, having wear and tear consequences for the human physiology. The investigators hypothesized that the number, duration and frequency of human exposures to wide gradient (> 8 ° C) of air temperature changes may be related to potential health problems. An intervention potentially reducing the health risk associated with extended exposure to high temperatures in the summer for Cypriots may be the temporary (for a few days or hours) stay in the villages of mountainous area. Most of the mountain communities in Cyprus have consistently lower mean ambient air temperatures of about 10 degrees Celsius than those in the cities, so the investigators anticipate not observing the metabolic hormone alterations induced while being in the city environment.
详细描述
A randomised crossover trial study design was used to: investigate the circadian patterns of metabolic adipokines (leptin, adiponectin and ghrelin hormones), using targeted biomarker measurements and untargeted metabolomics in healthy adults residing in two different climatological environments: urban and higher in latitude mountainous settings, and ii) investigate the effect of skin temperature gradient on the variation of adipokines in the two settings (urban and rural).
The study will take place in Cyprus. Participant recruitment will abide by the ethical principles and the guidelines of the National Bioethics Committee of Cyprus. Participants will be recruited after they read and complete the consent form and the whole study protocol is explained to them. Information about the study will be disseminated through flyers and through telephone communication via governmental and other non-profitable organizations that will contact community leaders of the area and help us collect and create a contact list of "Potential Participants". From there, potential participants will be informed about the study and screened for eligibility criteria via telephone.
Upon consent, the "Potential Participants List" will have to be randomized to assign the participants in to two different groups. A total of 50-60 subjects will be followed for a period of one week firstly in an urban environment and later, for the same period, in a village of the mountainous rural environment, during the summer period in Cyprus.
Once the researchers have names of potential participants, each name will be given a 2-digit code. This will be participant's study ID that will accompany participants answered questionnaires, diaries, urine vials and temperature measurement's files. The preparation of each tool with filled participants ID code and Date will be made at priory.
There will be no blinding since the interventions are known to the participants and the researchers. There will be the necessary blinding during the conduct of the all laboratory and statistical analyses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
There will be the necessary blinding during the conduct of the all laboratory and statistical analyses. At the start of the study, participants will be given a 2-digit code (10-60) - once the researchers have names of eligible participants, each name will be given a code. This will be participant's study ID that will accompany participant's answered questionnaires, diaries, urine vials and temperature measurement's files.
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults between 20-60 years old
- •Those that intend staying in mountainous area of Cyprus for the period of at least 1 week between July and September 2018
排除标准
- •Pregnant women
- •Obese individuals (>30 kg m-2)
- •Those that have travelled to another country within one week of the study start date.
- •People with history of hypertension or with diabetes or metabolic syndrome, or cancer.
- •People receiving pharmaceutical treatment for impaired glucose levels and/or hypertension and/or antidepressants or thyroxin for thyroid disorders.
研究组 & 干预措施
Urban setting
The participants will be staying in their permanent house in an urban area in Cyprus for at least 7 days. On the 7th day, they will be wearing 2 temperature sensors, for skin and air temperature. They will also collect the urine samples of the day and note in an activity diary, the names and times of activities.
Mountainous setting
The intervention is the short stay in the mountainous area of Troodos for atleast 7 consecutive days. The participants will be staying in their holiday house in the mountainous-rural area of Troodos, Cyprus for at least 7 days. On the 7th day, they will wear 2 temperature sensors, for skin and personal air temperature monitoring (every minute data points). They will also collect the urine samples of the day and note in an activity diary, the names and times of activities.
干预措施: Mountainous setting (Behavioral)
结局指标
主要结局
Change from baseline for adipokines (leptin, adiponectin and ghrelin) at day seven
时间窗: units of measure are the same for all these hormones as ng/g. 1 day in the mountainous setting and 1 day in the urban setting (three spot urine samples per day per participant)
First morning, and last before sleep of urinary adipokines measured with immunoassay kits
Change from baseline for stress hormones (melatonin and cortisol) at day seven
时间窗: units of measure for all these hormones as ng/g. 1 day in the mountainous setting and 1 day in the urban setting (three spot urine samples per day per participant)
First morning, last before sleep of cortisol/melatonin measured in urine with mass spectrometry
次要结局
- Metabolite differences(these will have the same units of measure as ug/g. 1 day in the mountainous setting and 1 day in the urban setting)
研究者
Konstantinos Makris
Dean and Associate Professor of Environmental Health at School of Health Sciences, Director of Water and Health Lab
Cyprus University of Technology