The Effect of Smoking on Thermoregulation

NCT ID: NCT01596556

Last Updated: 2014-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2014-05-31

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.

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.

Conditions

Cigarette Smoking

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

smokers

This arm consists of smokers.

Group Type: EXPERIMENTAL

Nicotine

Intervention Type: DRUG

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

cigarette smoking

Intervention Type: OTHER

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

non-smokers

non-smoking participants in the study

Group Type: ACTIVE_COMPARATOR

Nicotine

Intervention Type: DRUG

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

Interventions

Nicotine

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

Intervention Type: DRUG

cigarette smoking

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

International Diabetes Federation

OTHER

Sponsor Role: collaborator

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amit Druyan, M.D

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

The Institute of Military Physiology Heller Institute of Medical Research

Tel-Hashomer Ramat-Gan, , Israel

Countries

Israel

Other Identifiers

SHEBA-11-8767-AD-CTIL

Identifier Type: -

Identifier Source: org_study_id