The Effect of Smoking on Thermoregulation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
IDF
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01596556
First received: May 6, 2012
Last updated: February 13, 2013
Last verified: February 2013

May 6, 2012
February 13, 2013
June 2012
April 2013   (final data collection date for primary outcome measure)
  • Heat tolerance [ Time Frame: 2-3 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
  • Heat tolerance [ Time Frame: change from baseline after smoking or nicotine ingestion ] [ Designated as safety issue: No ]
    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: change from baseline after smoking or nicotine ingestion ] [ Designated as safety issue: No ]
    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.
Complete list of historical versions of study NCT01596556 on ClinicalTrials.gov Archive Site
  • Rectal temperature [ Time Frame: experimental days 4,5,6 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    During the HTT and the VO2 test heart rates will be monitored continuously and will be stored by a heart rate wristwatch, (POLAR, Finland).
  • Rectal temperature [ Time Frame: experimental days 4,5,6 ] [ Designated as safety issue: Yes ]
    The volunteers will undergo heat tolerance test. Their rectal tempreture will be mesured 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 ] [ Designated as safety issue: Yes ]
    During the HTT and the VO2 test heart rates will be monitored continuously and will be stored by a heart rate wristwatch, (POLAR, Finland).
Not Provided
Not Provided
 
The Effect of Smoking on Thermoregulation
The Effect of Smoking on Thermoregulation

To the best of our knowledge, a possible relation between smoking and heat injuries or heat intolerance was never scientifically examined, although such a relation is logical according to the observations that smoking has a thermogenic effect, decreases physical fitness and affects the body's heat dissipation.16 healthy young male volunteers will participate in the study, 8 smokers and 8 non-smokers. They will arrive to our lab four or six times. They will perform VO2 test and heat tolerance test (HTT) in different conditions.

16 healthy young male volunteers will participate in the study, 8 smokers and 8 non-smokers. They will arrive to our lab four or five times. During their first visit they will go through a VO2 max test in order to evaluate their aerobic fitness, and their physiological efficiency. During their second visit all subjects will go through the same test after exposure to nicotine. During the smokers' third visit they will go through the same test, after exposure to cigarette smoking. During the non-smokers third visit and the smokers fourth visit - they will go through an exercise heat tolerance test without prior smoking. During the fifth visit the smokers will go through an exercise heat tolerance test after exposure to cigarette smoking. During the smokers' sixth visit and the non-smokers fourth visit they will go through an HTT after exposure to nicotine.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Cigarette Smoking
  • Drug: Nicotine
    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.
  • Experimental: smokers
    This arm consists of smokers.
    Interventions:
    • Drug: Nicotine
    • Other: cigarette smoking
  • Active Comparator: non-smokers
    non-smoking participants in the study
    Intervention: Drug: Nicotine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
10
May 2013
April 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age 18-30
  • healthy
  • after medical checkup
  • after signing concent form
  • for the smokers: smoking 0.5-1.5 packs of cigarettes a day at least 2 years.

Exclusion Criteria:

  • heart disease
  • respiratory disease
  • baseline bp above 140/90 mmHg
  • diabetes
  • anhydrosis
  • skin disease
  • acute illness
  • detoxification from nicotine
  • allergy to nicotine
  • smoking other then specified in the inclusion criteria
Male
18 Years to 30 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01596556
SHEBA-11-8767-AD-CTIL
No
Sheba Medical Center
Sheba Medical Center
IDF
Principal Investigator: Amit Druyan, M.D Sheba Medical Center
Sheba Medical Center
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP