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| Name | Class |
|---|---|
| Qilu Hospital of Shandong University | OTHER |
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This is a randomized controlled human exposure crossover study. Investigators aims to assess the acute effects of high temperature exposure and the underlying mechanisms.
The objective of this study is to study changes in functions of multiple organs under heat exposure, which mainly include changes of cardiac function and lung function. In addition, biological samples such as blood samples, nasal fluid, and urine, etc were collected to explore changes in biomarkers such as complete blood count, liver function, kidney function, and inflammatory indicators, etc. Biochemical analysis and omics analysis were conducted to study the changes of human physiological function caused by heat exposure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High temperature group | Experimental | This group including 24 healthy subjects will be exposed to high temperature for about 3 hours in a chamber. |
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| Moderate temperature group | Sham Comparator | This group including 24 healthy subjects will be exposed to moderate temperature for about 3 hours in a chamber. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High temperature exposure | Other | Subjects will be exposed to 35 degree Celsius and 45% relative humidity for 3 hours, resting during the whole periods. |
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| Measure | Description | Time Frame |
|---|---|---|
| Systolic and diastolic blood pressure | Brachial arterial blood pressure will be measured | Systolic and diastolic blood pressure will be measured within 15 minutes before exposure and immediately after the exposure session, and every 15 minutes during exposure. |
| Cardiac output | Cardiac output will be measured by heart color ultrasound | Cardiac output will be checked within half an hour before exposure and immediately after exposure. |
| Heart rate variability | Heart rate variability will be measured using 24-hour holter electrocardiogram | Cardiac variability will be monitored in real time from half an hour before exposure to half an hour after exposure, with data automatically recorded every 8 seconds. |
| Change of forced expired volume in the first second (FEV1) | The changes of FEV1 will be measured by a smart spirometer. Before the pulmonary function test, subjects will practice several times by themselves. During the examination, each subject stands and clamps the nose clip, and repeats the test, with the best result as the criterion. | FEV1 will be checked within half an hour before exposure and 15 minutes after exposure. |
| Changes of forced vital capacity (FVC) | The changes of FVC will be measured by a smart spirometer. | FVC will be checked within half an hour before exposure and 15 minutes after exposure. |
| Changes of peak expiratory flow rate (PEF) | The changes of PEF will be measured by a smart spirometer. |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in metabolic profiling detected in blood between the two exposures and before and after each exposure | The differential metabolic profiling in peripheral blood related to high temperature exposure will be detected by mass spectrometry-based non-targeted metabolomics. | Prior to and 1 hour after exposure |
| Measure | Description | Time Frame |
|---|---|---|
| Change in tumor necrosis factor-α (TNF-α) concentrations | TNF-α will be tested through blood samples | Prior to and 1 hour after exposure |
| Change in C reactive protein (CRP) concentrations | CRP will be tested through blood samples |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong University | Jinan | Shandong | China |
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| ID | Term |
|---|---|
| D018882 | Heat Stress Disorders |
| D014947 | Wounds and Injuries |
| D001832 | Body Temperature Changes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Participants will be informed of the study interventions before providing informed consent but will be masked to the order of exposure (i.e., participants will not know the exposure conditions). Data will be blinded prior to analysis.
| Moderate temperature exposure | Other | Subjects will be exposed to 24degree Celsius and 45% relative humidity for 3 hours, resting during the whole periods. |
|
| PEF will be checked within half an hour before exposure and 15 minutes after exposure. |
| Changes of maximum expiratory flow rate at 25% vital capacity (MEF25) | The changes of MEF25 will be measured by a smart spirometer. | MEF25 will be checked within half an hour before exposure and 15 minutes after exposure. |
| Changes of maximum expiratory flow rate at 50% vital capacity (MEF50) | The changes of MEF50 will be measured by a smart spirometer. | MEF50 will be checked within half an hour before exposure and 15 minutes after exposure. |
| Changes of maximum expiratory flow rate at 75% vital capacity (MEF75) | The changes of MEF75 will be measured by a smart spirometer. | MEF75 will be checked within half an hour before exposure and 15 minutes after exposure. |
| Inflammatory factors and antioxidant-related biomarkers in nasal cavity fluid | Inflammatory factors were detected by the ELASA | Collect nasal fluid samples half an hour before exposure and half an hour after exposure |
| Differences in transcriptome detected in blood between the two exposures and before and after each exposure |
The differential transcriptome in peripheral blood related to high temperature exposure will be detected by mass spectrometry-based non-targeted transcriptomics. |
| Prior to and 1 hour after exposure |
| Differences in proteome detected in blood between the two exposures and before and after each exposure | The differentially expressed proteins in peripheral blood related to high temperature exposure will be detected by non-targeted proteomics | Prior to and 1 hour after exposure |
| EEG power in α band | EEG power in α band will be monitored by EEG measuring instrument | EEG power in α band will be measured immediately during the same exposure period the day before exposure and within half an hour of the end of the exposure day. |
| EEG power in θ band | EEG power in θ band will be monitored by EEG measuring instrument | EEG power in θ band will be measured immediately during the same exposure period the day before exposure and within half an hour of the end of the exposure day. |
| EEG power in β band | EEG power in β band will be monitored by EEG measuring instrument | EEG power in β band will be measured immediately during the same exposure period the day before exposure and within half an hour of the end of the exposure day. |
| EEG power in δ band | EEG power in δ band will be monitored by EEG measuring instrument | EEG power in δ band will be measured immediately during the same exposure period the day before exposure and within half an hour of the end of the exposure day. |
| Response event-related potentials (ERPs) | ERPs will be monitored by EEG measuring instrument, including P300, N1/P1 and so on. | ERPs will be measured immediately during the same exposure period the day before exposure and within half an hour of the end of the exposure day. |
| Frequency domain and energy ratio index, θ/β ratio | θ/β ratio will be monitored by EEG measuring instrument, which is an important parameter for response frequency domain and energy ratio index | θ/β ratio will be measured immediately during the same exposure period the day before exposure and within half an hour of the end of the exposure day. |
| Cerebral blood flow changes | Cerebral blood flow changes will be measured by transcranial doppler | Cerebral blood flow changes will be examed within half an hour before exposure and half an hour after exposure. |
| Differences in proteomics detected in nasal fluid between the two exposures and before and after each exposure | Collect nasal fluid samples for proteomics analysis | Prior to and 1 hour after exposure |
| Prior to and 1 hour after exposure |
| Change in interleukin-6 (IL-6) concentrations | IL-6 will be tested through blood samples | Prior to and 1 hour after exposure |
| Change in interleukin-1β (IL-1β) concentrations | IL-1β will be tested through blood samples | Prior to and 1 hour after exposure |
| Change in liver function indicators | Liver function indexes will be tested through blood samples, including glutamic-pyruvic transaminase (ALT), glutamic oxalacetic transaminase (AST), glutamyltranspeptidase (GGT), alkaline phosphatase (ALP), total protein (TP), albumin(ALB), total bilirubin (TBIL), direct bilirubin (DBIL) and so on. | Prior to and 1 hour after exposure |
| Change in kidney function indicators | Liver function indexes will be tested through blood samples, including urea nitrogen (BUN), creatinine (CR), Cystatin C (CYS C) and so on. | Prior to and 1 hour after exposure |
| Change in Uric Acid (UA) | UA will be tested through blood samples | Prior to and 1 hour after exposure |
| Change in myocardial and vascular injury indicators | myocardial and vascular injury indicators will be tested through blood samples, including creatine kinase (CK), Creatine Kinase Isoenzyme (CKMB), lactic dehydrogenase (LDH), α-hydroxybutyrate kinase and so on. | Prior to and 1 hour after exposure |
| Change in coagulation indicators | Coagulation indicators will be tested through prothrombin time(PT), activated partial thromboplastin time (APTT), plasma fibrinogen (FIB), thrombin time (TT) and so on. | Prior to and 1 hour after exposure |
| Blood routine examination | A routine test in the blood test, including red blood cells, white blood cells, platelets and other aspects of the test. | Prior to and 1 hour after exposure |
| Routine urianlysis | A routine test in the urine sample, including urine specific gravity and so on. | Prior to and 1 hour after exposure |
| Change in D-lactic acid | D-lactic acid will be tested through blood samples | Prior to and 1 hour after exposure |
| Change in diamine oxidase(DAO) | DAO will be tested through blood samples | Prior to and 1 hour after exposure |
| Weight | Weight will be measured using a scale, wearing only short-sleeved shorts and slippers | Prior to exposure and immediately after the exposure session |