The Effect of Smoking on Thermoregulation

Sponsor

Sheba Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01596556

Collaborator

International Diabetes Federation (Other)

Enrollment

Location

Arms

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Cigarette Smoking	Drug: Nicotine Other: cigarette smoking	N/A

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 Design

Study Type:

Interventional

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 :

Jun 1, 2012

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

May 1, 2014

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Heat tolerance [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.
VO2max [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

Rectal temperature [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
Heart rate [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

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:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sheba Medical Center

ClinicalTrials.gov Identifier:

NCT01596556

Other Study ID Numbers:

SHEBA-11-8767-AD-CTIL

First Posted:

May 11, 2012

Last Update Posted:

May 9, 2014

Last Verified:

May 1, 2014

Keywords provided by Sheba Medical Center

Additional relevant MeSH terms:

Nicotine

Study Results

No Results Posted as of May 9, 2014