To investigate cognitive performance in relation to glucose tolerance in elderly subjects.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Assessment of peripheral glucose regulation by means of the standard 2-h
oral glucose tolerance test (OGTT)
2. Assessment of cognitive performance by means of a computerized validated
test system.
Secondary outcome
not applicable
Background summary
A strong association exists between abnormalities in glucose tolerance and
adverse health outcomes, such as development of type 2 diabetes and
cardiovascular disease. Several lines of evidence suggest that abnormalities in
glucose tolerance are also associated with impaired cognitive performance.
Previous studies have also shown that glucose administration enhances cognitive
performance in healthy subjects and in subjects with memory deficits or poor
glucose regulation.
In this study, a number of selected validated cognitive tests will be used to:
1) evaluate the association between cognitive performance and blood glucose
regulation in a random sample of the elderly population. Cognitive tests are
selected that target the cognitive domains being most sensitive to the effects
of glucose tolerance, i.e. memory, vigilance, and attention;
2) evaluate the effect of glucose when considering the relationship between
glucose tolerance and cognition, or in other words, to evaluate whether worse
glucoregulators receive a greater cognitive benefit from glucose consumption
than better glucoregulators.
Study objective
To investigate cognitive performance in relation to glucose tolerance in
elderly subjects.
Study design
An open study. All subjects visit the institute once for OGTT and cognition
tests.
Intervention
The intervention is part of the oral glucose tolerance test (OGTT) and consists
of single administration of 75 g glucose dissolved in 300 ml water.
Study burden and risks
The burden of participation involves: filling in a questionnaire on health and
lifestyle for screening, fasting from 22:00 h the evening before the test day,
consumption of a glucose solution, no eating, drinking, smoking during the
OGTT, possibly nausea and faintness due to the glucose solution, 2x blood
sampling (ca. 17 ml), 2x conducting cognition tests on a computer.
Participation is not likely associated with any physical and physiological
discomfort.
Utrechtseweg 48
Postbus 360 Zeist
Nederland
Utrechtseweg 48
Postbus 360 Zeist
Nederland
Listed location countries
Age
Inclusion criteria
1. Healthy as assessed by the TNO health and lifestyle questionnaire (short version)
2. Age 65-75 y (boundaries included) at Day 01 of the study
3. Able to perform easy actions on a computer
4. Voluntary participation
5. Having given written informed consent
6. Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years
7. Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned.
Exclusion criteria
1. Having (a history of) medical or surgical events that may significantly affect the study outcome, including psychiatric disorders, diabetes
2. Use of medication for diabetes
3. Alcohol consumption > 28 units/week for males and > 21 units/week for females
4. Personnel of TNO Quality of Life, their partner and their first and second degree relatives
5. Not having a general practitioner
6. Not willing to accept information-transfer regarding his/her health, like laboratory results, findings at anamnesis and eventual adverse events to and from his general practitioner.
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 | NL32593.028.10 |