To assess the effect of low intensity physical activity on plasma insulin levels, cognition and mood in subjects with overweight/obesity
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• To assess the effect of low intensity physical activity (LIPA) on plasma
insulin levels (as measured as area under the curve during an oral glucose
tolerance test)
Secondary outcome
Secondary objectives:
• To assess the effect of LIPA on insulin sensitivity
• To assess the effect of LIPA on plasma C-peptide and glucose levels
• To assess the effect of LIPA on lipid metabolism
• To assess the effect of LIPA on mood and cognitive performance
• To assess the effect of LIPA on Quality of Life and sleep
• To explore the association between plasma glucose, plasma insulin, insulin
sensitivity and mood, cognitive performance, Quality of Life and sleep
• To assess the effect of LIPA on inflammation and endothelium
• To assess the effect of LIPA on blood pressure
• Insulin like growth factor 1 (IGF-1) and growth hormone (GH)
Background summary
A sedentary lifestyle and obesity are well known risk factors of type 2
diabetes. The major focus of current guidelines for type 2 diabetes prevention
is on energy balance. Physical activity guidelines recommend at least 30
minutes/day of moderate to vigorous physical activity (MVPA). However, no
advice is given how the other 23.5 hours of the day should be spent. Several
recent epidemiologic studies suggest that excessive sitting, independent of
moderate to vigorous physical activity, has detrimental health effects. Another
possibility to sit less is by increasing low intensity physical activities as
slowly walking and standing. A recent published study of our research group
(Duvivier et al. PLOS ONE 2013) suggests that sitting less and replacing it by
slowly walking and standing has a better effect on insulin action and
cardiovascular risk factors than the combination of one hour MVPA per day and
sitting the rest of the day. Until now this research is not performed in
subjects with overweight/obesity.
Study objective
To assess the effect of low intensity physical activity on plasma insulin
levels, cognition and mood in subjects with overweight/obesity
Study design
intervention study
Intervention
2 activity regimes of 4 days: a sitting regime and a "sit less" regime
Study burden and risks
The blood samples taken during the oral glucose tolerance test are relatively
non-invasive with little risks. Risks are: bruising, fainting and vomiting
after insertion of the needle.
During the test day the subjects will be asked to drink a glucose drink (75
gram glucose) and to fill in/complete cognition tests and questionnaires
(sleep, mood, quality of life).
The following activities will strongly affect daily activities of the subjects:
- Noting down the activities each hour in a diary
- Following the number of hours walking/sitting/standing/sleeping of the
activity regimes
- Following the same diet as during the first activity regime
- Visiting the university 8 times during 5 weeks
The subjects will be informed that the study will strongly affect daily
activities.
Olivier van Noortlaan 120
Vlaardingen 3133 AT
NL
Olivier van Noortlaan 120
Vlaardingen 3133 AT
NL
Listed location countries
Age
Inclusion criteria
o Signed informed consent
o Men and postmenopausal women: 40-80 years old
o BMI: 25.0 - 35.0 kg/m2
o Maximum 2.5 hours of MVPA per week (during last 3 months)
o Having a general practitioner
o Agreeing to be informed about medically relevant personal test-results by a physician
o Accessible veins on arms as determined by examination at screening
Exclusion criteria
o Reported participation in another biomedical trial which may have an effect on insulin sensitivity one month before the pre-study examination or during the study
o Blood donation in the past three months
o Reported participation in night shift work 2 weeks prior to pre-study investigation or during the study. Night work is defined as working between midnight and 6.00 AM.
o Consumption of >14 (women) or > 21 (men) alcoholic units per week
o Reported dietary habits: medically prescribed diet, slimming diet;
o Reported weight loss (>2kg) in the last three months prior to the screening;
o Not being able to execute at least three (out of four) cognition tests in the training session
o Not being able to execute the sit less try-out day
o Being an employee of Unilever or the collaborating research departments in Maastricht University Medical Centre
o Experimental drug use (during the last 3 months)
o Use of insulin, oral blood glucose lowering medication (metformin and/or SU-derivatives and/or DPP-IV inhibitors), corticosteroids or vitamin K antagonists in the last 3 months
o Fasting plasma glucose level > 6.9 mmol/L
o Medical conditions which make participation in the study not responsible which will be decided by a medical doctor during screening
o Other clinically relevant abnormalities in clinical chemistry at screening (to be judged by a medical doctor)
o Mental or physical disability which interferes with physical activity
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 | NL50688.068.14 |
| Other | volgt (www.clinicaltrials.gov) |