The primary goal is to compare the physiological stress and strain of the thermoregulation, fluid- and electrolyte balance between lean and obese participants of the Nijmegen 4-Day Marches. Furthermore, we aim to compare general characteristics,…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Inspannings gerelateerde gezondheidsrisico's (thermoregulatie, vocht- en electrolytenbalans)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) Blood determinations (lipid- and insulin profile, electrolytes, hematocrit,
hemoglobine, creatine kinase, troponin)
2) Fluid intake and urine output
3) Core body temperature, skin temperature and heart rate
4) Energy expenditure
5) Personal characteristics (questionnaire)
6) Blood vessel quality (IMT of the a. carotis)
7) Ambient conditions
Secondary outcome
1) Urine analysis
2) Body weight (changes)
3) General characteristics
4) Blood pressure
Background summary
Obesity is a large problem in The Netherlands and currently 50% of all Dutch
adults has a body mass index above 25. Even in a relative active population,
such as the Nijmegen Marches population, overweight and obesity is present. The
average BMI in a random sample of 5000 4-Day Marches participants was 24.7,
with 35% and 5% of these adults being overweight and obese respectively.
Several studies showed that a high BMI is correlated with problems in
thermoregulation and an increased risk for the development of renal problems.
Past years, the department of Physiology showed that core body temperature
increased markedly in all participants of the Nijmegen Marches. Furthermore 20%
of the participants showed an electrolyte disbalance at one or more days.
However, it is unknown whether participants with obesity have an increased risk
compared to lean controls. Therefore this study will compare the parameters of
thermoregulation, fluid- and electrolyte balance between a group obese (BMI>30)
and lean (BMI<25) participants of the Nijmegen 4-Day Marches. In addition, the
level of physical activity in subjects with obesity seems to be important,
since large differences in health related risks are observed between active and
inactive obese subjects. Therefore we will include an obese inactive control
group (non-participants of the Nijmegen Marches). General characteristics,
blood analysis, blood vessel quality (IMT) and the results of a health
questionnaire will be compared between the active and inactive group of obese
subjects.
Study objective
The primary goal is to compare the physiological stress and strain of the
thermoregulation, fluid- and electrolyte balance between lean and obese
participants of the Nijmegen 4-Day Marches. Furthermore, we aim to compare
general characteristics, blood analysis, blood vessel quality (IMT) and the
results of a health questionnaire between obese participants and obese
(inactive) non-participants of the Nijmegen 4-Day Marches.
Study design
Observational study
Study burden and risks
In addition to a questionnaire, heart rate monitor, activity monitor, skin
thermometer (subgroup), food and fluid diary and determination of body weight,
subjects receive a sensor pill that record core body temperature. The latter
assessment is a safe, valid and 'friendly' method to record core body
temperature. Furthermore blood and urine will be taken to gain insight into the
fluid and electrolytebalance.The burden of these tests are, physical as well as
in time, minimal and privide important information which is necessary for the
primary aim of the study.
Postbus 9101
6500 HB Nijmegen
NL
Postbus 9101
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
- older than 18 years
- Group 1: participant of 4-Day marches / BMI<25
- Group 2: participant of 4-Day marches / BMI>30
- Group 3: non-participant of 4-Day marches/ inactive (<1 hour exercise per week) / BMI>30
Exclusion criteria
obstructive disease of the gastro-intestinal tract, including diverticulitis and inflammatory bowel disease
- previous gastrointestinal surgery, except cholecystectomy and appendectomy
- MRI during the period that the CorTemp sensor is within the body (e.g. 1 day preceding the 4-Day Marches, during the 4-Day Marches and 2 days after the the 4-Day Marches)
- subject having a cardiac pacemaker or other implanted electromedical device.
Design
Recruitment
Medical products/devices used
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 | NL27818.091.09 |