The Effect of Smoking on Thermoregulation
|ClinicalTrials.gov Identifier: NCT01596556|
Recruitment Status : Completed
First Posted : May 11, 2012
Last Update Posted : May 9, 2014
|Condition or disease||Intervention/treatment||Phase|
|Cigarette Smoking||Drug: Nicotine Other: cigarette smoking||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||The Effect of Smoking on Thermoregulation|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||May 2014|
This arm consists of smokers.
both groups will be given nicotine lozenges before a VO2 test and a HTT.Other: cigarette smoking
the smokers will smoke 2 cigarettes before a VO2 exam and a HTT.
Active Comparator: non-smokers
non-smoking participants in the study
both groups will be given nicotine lozenges before a VO2 test and a HTT.
- Heat tolerance [ Time Frame: 2-3 days ]The test is performed in a climatic chamber at a temperature of 40oC and 40% relative humidity. During the test, the subject walks on a treadmill at a speed of 5 km/hr at a 2% grade for 2h. Body core temperature and heart rate are continuously monitored, and sweat rate is computed from body weight prior to and after the test, corrected for fluid intake. Heat intolerance is determined when body core temperature elevates above 38.5oC, when heart rate elevates above 150 bpm, or when either does not tend to reach a plateau.
- VO2max [ Time Frame: 2-3 days ]volunteer's oxygen consumption (VO2) will be monitored continuously with a metabolic chart (ZAN), while running for 10 min on a treadmill under comfortable environmental conditions.
- Rectal temperature [ Time Frame: experimental days 4,5,6 ]The volunteers will undergo heat tolerance test. Their rectal temperature will be measured by rectal thermistor and will be monitored continuously and viewed by the attending medical staff. Automatically all data will be recorded by the monitoring Biopac system
- Heart rate [ Time Frame: experimental days 4,5,6 ]During the HTT and the VO2 test heart rates will be monitored continuously and will be stored by a heart rate wristwatch, (POLAR, Finland).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01596556
|The Institute of Military Physiology Heller Institute of Medical Research|
|Tel-Hashomer Ramat-Gan, Israel|
|Principal Investigator:||Amit Druyan, M.D||Sheba Medical Center|