The Effect of Smoking on Thermoregulation

Cigarette Smoking Clinical Trial

Official title:

The Effect of Smoking on Thermoregulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01596556
• Other study ID #: SHEBA-11-8767-AD-CTIL
• Status: Completed
• Phase: N/A
• First received: May 6, 2012
• Last updated: May 8, 2014
• Start date: June 2012
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cigarette Smoking

Intervention

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.

Locations

Country	Name	City	State
Israel	The Institute of Military Physiology Heller Institute of Medical Research	Tel-Hashomer Ramat-Gan

Sponsors (2)

Lead Sponsor	Collaborator
Sheba Medical Center	International Diabetes Federation

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2-3 days	No
Primary	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.	2-3 days	No
Secondary	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	experimental days 4,5,6	Yes
Secondary	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).	experimental days 4,5,6	Yes