We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Smoking on Thermoregulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01596556
Recruitment Status : Completed
First Posted : May 11, 2012
Last Update Posted : May 9, 2014
Sponsor:
Collaborator:
International Diabetes Federation
Information provided by (Responsible Party):
Sheba Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment
Cigarette Smoking Drug: Nicotine Other: cigarette smoking

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
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
Primary Completion Date : December 2013
Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking
U.S. FDA Resources

Arm Intervention/treatment
Experimental: smokers
This arm consists of smokers.
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.
Active Comparator: non-smokers
non-smoking participants in the study
Drug: Nicotine
both groups will be given nicotine lozenges before a VO2 test and a HTT.



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01596556


Locations
Israel
The Institute of Military Physiology Heller Institute of Medical Research
Tel-Hashomer Ramat-Gan, Israel
Sponsors and Collaborators
Sheba Medical Center
International Diabetes Federation
Investigators
Principal Investigator: Amit Druyan, M.D Sheba Medical Center

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01596556     History of Changes
Other Study ID Numbers: SHEBA-11-8767-AD-CTIL
First Posted: May 11, 2012    Key Record Dates
Last Update Posted: May 9, 2014
Last Verified: May 2014

Keywords provided by Sheba Medical Center:
smoking
exercise
heat tolerance
heat stroke

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action