The Effect of Smoking on Thermoregulation

This study has been completed.
Sponsor:
Collaborator:
International Diabetes Federation
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01596556
First received: May 6, 2012
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

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 Intervention
Cigarette Smoking
Drug: Nicotine
Other: cigarette smoking

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: The Effect of Smoking on Thermoregulation

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 16
Study Start Date: June 2012
Study Completion Date: May 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01596556     History of Changes
Other Study ID Numbers: SHEBA-11-8767-AD-CTIL
Study First Received: May 6, 2012
Last Updated: May 8, 2014
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

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

ClinicalTrials.gov processed this record on July 23, 2014