CClinicalTrials.gg
CompletedNCT01596556Updated May 9, 2014

The Effect of Smoking on Thermoregulation

An interventional study of Nicotine and cigarette smoking in Cigarette Smoking, sponsored by Sheba Medical Center. Completed at 1 site in Israel. Open to male participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-05-09.

Sponsored by Sheba Medical Center · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Non-randomized
Ages
18 Years to 30 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Cigarette Smoking

Keywords

  • smoking
  • exercise
  • heat tolerance
  • heat stroke
03

In context

Lead sponsor

Sheba Medical Center is the lead sponsor of 660 studies on the registry; 63 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    smokers

    This arm consists of smokers.

    Drug: Nicotine · Other: cigarette smoking

  • Active comparator
    non-smokers

    non-smoking participants in the study

    Drug: Nicotine

Interventions

  • DrugNicotine

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

  • Othercigarette smoking

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

06

What researchers measure

Primary outcomes

  1. Heat tolerance

    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.

    Time frame: 2-3 days

  2. VO2max

    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.

    Time frame: 2-3 days

Secondary outcomes

  1. Rectal temperature

    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

    Time frame: experimental days 4,5,6

  2. Heart rate

    During the HTT and the VO2 test heart rates will be monitored continuously and will be stored by a heart rate wristwatch, (POLAR, Finland).

    Time frame: experimental days 4,5,6

07

Study locations

1 site
  • The Institute of Military Physiology Heller Institute of Medical Research
    Tel-Hashomer Ramat-Gan, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01596556
Lead sponsor
Sheba Medical Center
Collaborators
International Diabetes Federation
Responsible party
Sponsor
First posted
May 11, 2012
Start date
Jun 2012
Primary completion
Dec 2013
Completion
May 2014
Last update
May 9, 2014

Study contacts

Amit Druyan, M.D
principal investigator · Sheba Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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