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Completed

NCT Number: NCT01596556

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.

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Key information

Conditions

Cigarette Smoking Behavior Heat Stress Disorders Heat Stroke Motor Activity Smoking Tobacco Smoking Tobacco Use Wounds and Injuries

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

The Institute of Military Physiology Heller Institute of Medical Research

Tel-Hashomer Ramat-Gan, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nicotine

Drug

both groups will be given nicotine lozenges before a VO2 test and a HTT.

cigarette smoking

Other

the smokers will smoke 2 cigarettes before a VO2 exam and a HTT.

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Collaborators

  • International Diabetes Federation

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
May 11, 2012
Registry last updated
May 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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