Temperature Change, BodyTEMPNCT03625817
Skin Temperature Gradient Effects on the Variation of Metabolic Hormones in Adults
A study testing Mountainous setting in people with Temperature Change, Body and Stress, run by Cyprus University of Technology at 1 site in Cyprus.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Temperature Change, Body, Stress, Metabolic Disturbance
- What is being tested?
- Mountainous setting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteCyprus
- Study dates
- 17 Jul 2018to 10 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Cyprus1 site
Cyprus International Institute of Environmental and Public Health
Limassol, 3041
About this study
Official title: 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
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.
Read the detailed description
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.
The field workers and participants will arrange four visits. Visit 1 and 3 will take place one day before the sampling day which is the last day at each site(urban Vs rural), whereas visit 2 and 4 will take place a day after the sampling day when collection of the data will take place.
Except the preparation for the first sampling day during the first visit, participants will be asked to sign the informed consent form and to fill in two survey questionnaires (baseline characteristics and chronotype questionnaire). During sampling days, participants will be handed with the diary of activities, urine vials for urine sample collection and the instructions form (for urine collection and the use of the personal temperature sensors). Electronic temperature sensors should be activated by the researchers on the spot and placed on the participant during the first and third visit. The temperature data collection will be ensured on the spot during the second and forth visit. Participants will be asked to collect urine voids by collecting all bladder content during urination in vials provided by the Water and Health Lab. The first urine void of each sampling day will be discarded. All urine voids for the rest of the sampling day, of each participant, will be collected, including the first urine void of the following day. Samples will be kept at a freezer by the participant until collected by a member of the research team, in cool boxes. Upon arrival at the Water and Health lab samples, aliquoting will take place and then aliquot samples will be stored in freezers of -80◦C, until analysis.
Data collected will be digitized, anonymized and statistically evaluated. All data management steps will be employed to ensure that a final, clean, tidy and replicable dataset will be produced before proceeding to the statistical analysis. Descriptive statistics of the study population will be performed that will include parameters such as the mean and standard deviation for continuous variables and percentages for variables that indicate proportions.
The effect of temperature gradient changes and hormonal level, as well as, differences in cortisol levels between and within subject variation will be examined. The statistical analyses will include a range of approaches from descriptive statistics to regression analysis and metabolomics analyses. Pre-post analyses, non-linear mixed effects models, will be used to identify correlations of the circadian rhythms of the participants between the two settings. Statistical evaluation and graphical presentation of results will be prepared for a final report and presentation. All statistical analyses will be conducted at the Water and Health laboratory.
- Conditions
- Temperature Change, Body, Stress, Metabolic Disturbance
- Being tested
- Mountainous setting
- Medical subject headings
- Body Temperature Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mountainous settingBehavioural
The mountainous setting is characterized by lower temperatures (about 8-10C ambient air temp.) than those in urban setting, also having >800m altitude.Each period will last for 1 week with a wash out period of minimum 2 days. Continuous skin temperature and ambient temperature monitoring will take place in the last day of each period, towards the end. During the 2 sampling days, 24-hour urine voids will be collected in different vials. Participants will be required to fulfill a diary with their daily activities, meal times, collection of urine times, sleep/wake times and times of leaving/entering a closed environment.
| Study group | Role | What they receive |
|---|---|---|
| Urban setting | No intervention | 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 | Experimental | 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. Receives: Behavioral: Mountainous setting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline for adipokines (leptin, adiponectin and ghrelin) at day seven
First morning, and last before sleep of urinary adipokines measured with immunoassay kits
Measured: 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)
Change from baseline for stress hormones (melatonin and cortisol) at day seven
First morning, last before sleep of cortisol/melatonin measured in urine with mass spectrometry
Measured: 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)
Secondary outcomes (1)
Metabolite differences
Differentiated metabolite change (fold change) for metabolomics platform-based profiles of in two study settings with distinctly different climatological characteristics.
Measured: these will have the same units of measure as ug/g. 1 day in the mountainous setting and 1 day in the urban setting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start17 Jul 2018
- Primary completion30 Sep 2018
- Study completion10 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Temperature Change, BodyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A 2 x 2 cross-over pilot study of healthy adults is proposed to prospectively describe the effect of ambient temperature gradient on metabolic hormonal secretion patterns. A total of 50-60 subjects will be followed for a period of 7 days firstly in an urban environment or in a village of the mountainous rural environment and later, for the same period, in the alternate setting, during the summer period in Cyprus. The two settings will allow for the comparison of the circadian patterns of hormones secreted by the adipose tissue among different gradient temperature changes. Continuous quantification of skin temperatures on one day in each setting will allow for characterization of how skin temperature is affected by ambient temperature. Collection of all urine voids in one day in each setting will allow for quantification of the hormone secretion by the adipose tissue.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cyprus University of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantinos Makris, Cyprus University of Technology
- Investigators
- Konstantinos C Makris, PhD, Principal investigator, Cyprus International Institute of Environmental and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03625817
- Sponsor's protocol ID
- CUT2
- Acronym
- TEMP
- Status last verified
- Oct 2018
- First submitted
- 13 Jul 2018
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Urine Analysis data of the individual are to be saved and used for future research, after participants' consent.
Publications
Makris KC, Charisiadis P, Delplancke T, Efthymiou N, Giuliani A. Diurnal Nonlinear Recurrence Metrics of Skin Temperature and Their Association with Metabolic Hormones in Contrasting Climate Settings: A Randomized Cross-Over Trial. Int J Environ Res Public Health. 2022 Nov 17;19(22):15195. doi: 10.3390/ijerph192215195.
PubMed 36429912
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03625817
- Acronym / sponsor ID
- TEMP / CUT2
- Conditions
- Temperature Change, Body, Stress, Metabolic Disturbance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Cyprus University of TechnologyUniversity, hospital or other
- Study start
- 17 Jul 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 10 Oct 2018 (actual)
- First posted
- 10 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
The field workers and participants will arrange four visits. Visit 1 and 3 will take place one day before the sampling day which is the last day at each site(urban Vs rural), whereas visit 2 and 4 will take place a day after the sampling day when collection of the data will take place.
Except the preparation for the first sampling day during the first visit, participants will be asked to sign the informed consent form and to fill in two survey questionnaires (baseline characteristics and chronotype questionnaire). During sampling days, participants will be handed with the diary of activities, urine vials for urine sample collection and the instructions form (for urine collection and the use of the personal temperature sensors). Electronic temperature sensors should be activated by the researchers on the spot and placed on the participant during the first and third visit. The temperature data collection will be ensured on the spot during the second and forth visit. Participants will be asked to collect urine voids by collecting all bladder content during urination in vials provided by the Water and Health Lab. The first urine void of each sampling day will be discarded. All urine voids for the rest of the sampling day, of each participant, will be collected, including the first urine void of the following day. Samples will be kept at a freezer by the participant until collected by a member of the research team, in cool boxes. Upon arrival at the Water and Health lab samples, aliquoting will take place and then aliquot samples will be stored in freezers of -80◦C, until analysis.
Data collected will be digitized, anonymized and statistically evaluated. All data management steps will be employed to ensure that a final, clean, tidy and replicable dataset will be produced before proceeding to the statistical analysis. Descriptive statistics of the study population will be performed that will include parameters such as the mean and standard deviation for continuous variables and percentages for variables that indicate proportions.
The effect of temperature gradient changes and hormonal level, as well as, differences in cortisol levels between and within subject variation will be examined. The statistical analyses will include a range of approaches from descriptive statistics to regression analysis and metabolomics analyses. Pre-post analyses, non-linear mixed effects models, will be used to identify correlations of the circadian rhythms of the participants between the two settings. Statistical evaluation and graphical presentation of results will be prepared for a final report and presentation. All statistical analyses will be conducted at the Water and Health laboratory.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A 2 x 2 cross-over pilot study of healthy adults is proposed to prospectively describe the effect of ambient temperature gradient on metabolic hormonal secretion patterns. A total of 50-60 subjects will be followed for a period of 7 days firstly in an urban environment or in a village of the mountainous rural environment and later, for the same period, in the alternate setting, during the summer period in Cyprus. The two settings will allow for the comparison of the circadian patterns of hormones secreted by the adipose tissue among different gradient temperature changes. Continuous quantification of skin temperatures on one day in each setting will allow for characterization of how skin temperature is affected by ambient temperature. Collection of all urine voids in one day in each setting will allow for quantification of the hormone secretion by the adipose tissue.
| Arm | Type | Receives |
|---|---|---|
| Urban setting | No intervention | –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 | Experimental | Behavioral: Mountainous settingThe 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mountainous settingThe mountainous setting is characterized by lower temperatures (about 8-10C ambient air temp.) than those in urban setting, also having >800m altitude.Each period will last for 1 week with a wash out period of minimum 2 days. Continuous skin temperature and ambient temperature monitoring will take place in the last day of each period, towards the end. During the 2 sampling days, 24-hour urine voids will be collected in different vials. Participants will be required to fulfill a diary with their daily activities, meal times, collection of urine times, sleep/wake times and times of leaving/entering a closed environment. | Behavioural | Mountainous setting |
Primary outcome
Change from baseline for adipokines (leptin, adiponectin and ghrelin) at day seven
Time frame: 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
Time frame: 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
1 secondary outcome
Metabolite differences
Time frame: these will have the same units of measure as ug/g. 1 day in the mountainous setting and 1 day in the urban setting
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Derived from this study: PubMed 36429912Makris KC, Charisiadis P, Delplancke T, Efthymiou N, Giuliani A. Diurnal Nonlinear Recurrence Metrics of Skin Temperature and Their Association with Metabolic Hormones in Contrasting Climate Settings: A Randomized Cross-Over Trial. Int J Environ Res Public Health. 2022 Nov 17;19(22):15195. doi: 10.3390/ijerph192215195.
- Individual participant dataSharing planned: Undecided. Urine Analysis data of the individual are to be saved and used for future research, after participants' consent.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Konstantinos C Makris, PhD principal investigator
Cyprus International Institute of Environmental and Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mountainous setting in people with Temperature Change, Body and Stress, run by Cyprus University of Technology at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline for adipokines (leptin, adiponectin and ghrelin) at day seven (time frame: 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03625817, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2018.