The primary objective of the study is to examine the changes in core body temperature during a 60 minute cycling exercise bout at 85% of maximum predicted heart rate using double blind placebo or paracetamol in a group of healthy young subjects.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
hyperthermie (inspanningsgerelateerd)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Core body temperature (continuous)
2. Plasma levels of pyrogens (IL-1, IL-6, TNF en IFNg)
Secondary outcome
n/a
Background summary
Exercise represents a strong stimulus for heat production in humans. Although
heat dissipating mechanisms are activated rapidly after the onset of exercise
and the subsequent rise in core body temperature, a strong increase in core
body temperature can be observed in healthy subjects when performing exercise.
Whilst resting core body temperature is well regulated between 36.5-37.5 °C,
exercise can, dependent on various factors (duration, type and intensity of
exercise) and external factors (air temperature, humidity, clothing), increase
core body temperature up to 41 °C. Recent studies have demonstrated that acute
exercise is associated with the production of pyrogens, such as interleukin-1
and -6. These pyrogens may contribute to the increase in core body temperature,
providing evidence against the widely adopted believe that the increase in core
body temperature during exercise is fully explained by heat accumulation due to
a imbalance between heat production and heat dissipation.
Study objective
The primary objective of the study is to examine the changes in core body
temperature during a 60 minute cycling exercise bout at 85% of maximum
predicted heart rate using double blind placebo or paracetamol in a group of
healthy young subjects.
Study design
single centre, pilot study
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: Submaximal bicycle exercise tests are safe in
healthy volunteers without hypertension, normal ECG and without signs of
cardiovascular disease. Also administration of paracetamol is safe, whilst this
commonly used drug is not associated with important side effects or
complications.
Geert Grooteplein-noord 21
6525 EZ Nijmegen
NL
Geert Grooteplein-noord 21
6525 EZ Nijmegen
NL
Listed location countries
Age
Inclusion criteria
• Age : 18-45 years
• Willing to sign informed consent
• Healthy
Exclusion criteria
- hypersensitivity or idiosyncratic reaction to paracetamol.
- pregnant or lactating women.
- hepatic and/or renal impairment from participation.
- Because of potential interaction with other medication, we will exclude subjects with cholestyramine (which reduced the absorption speed of paracetamol), metoclopramide or domperidone (which speed of absorption of paracetamol is increased), warfarin (increased risk of bleeding) or chloramphenicol (increased plasma levels of chloramphenicol).
- obstructive disease of the gastro-intestinal tract (including diverticulitis and inflammatory bowel disease or previous gastrointestinal surgery, except cholecystectomy and appendectomy)
- subjects that will undergo a MRI-scan within 2 days after one of the testing days
- subjects with a cardiac pacemaker or other implanted electromedical devices
- As subjects will be performing a submaximal cycling test, we will also exclude:
• Hypertension (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg)
• Any cardiovascular abnormality in past medical history, physical examination or ECG, including prolonged QTc interval.
• BMI>=30 kg/m2
• Inability to perform bicycle exercise
• The presence of an absolute or relative contra-indication for exercise testing
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL36213.091.11 |