The Effect of Smoking on Thermoregulation

NCT01596556 | Completed

• 1 other identifier: SHEBA-11-8767-AD-CTIL
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Cigarette Smoking

Keywords

smoking; exercise; heat tolerance; heat stroke

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (2)

• Rectal temperature

  experimental days 4,5,6

• Heart rate

  experimental days 4,5,6

Study Arms (2)

smokers

EXPERIMENTAL

This arm consists of smokers.

Drug: Nicotine; Other: cigarette smoking

non-smokers

ACTIVE COMPARATOR

non-smoking participants in the study

Drug: Nicotine

Interventions

Nicotine DRUG

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

non-smokers; smokers

cigarette smoking OTHER

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

smokers

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• heart disease
• respiratory disease
• baseline bp above 140/90 mmHg
• diabetes
• anhydrosis
• skin disease
• acute illness
• detoxification from nicotine
• allergy to nicotine

Sponsors & Collaborators

• Sheba Medical Center: lead
• International Diabetes Federation: collaborator

Study Sites (1)

The Institute of Military Physiology Heller Institute of Medical Research

Tel-Hashomer Ramat-Gan, Israel

Location

MeSH Terms

Conditions

Cigarette Smoking; Smoking; Motor Activity; Heat Stroke

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Tobacco Smoking; Behavior; Tobacco Use; Heat Stress Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Amit Druyan, M.D

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2012
• First Posted: May 11, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: May 1, 2014
• Last Updated: May 9, 2014

Record last verified: 2014-05

Locations

IL (1)