Are changes in cognitive functioning related to structural changes in the brain in patients with type 1 diabetes mellitus. How are these changes related to diabetic complications like duration of chronic hypoglycaemia, disease duration and presence…
ID
Source
Brief title
Condition
- Diabetic complications
- Retina, choroid and vitreous haemorrhages and vascular disorders
- Encephalopathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cognitive performance; brain structure and function.
Secondary outcome
Biological measures like MBL, APO E and AGE's
Background summary
There is increasing evidence that individuals with type 1 diabetes (T1DM) are
susceptible to mild deficits in cognitive performance. There is growing
evidence that longstanding, chronic hyperglycaemia, and not severe
hypoglycaemia, is related to these cognitive changes. The question arises
whether and to what extend these cognitive changes are related to structural
and functional changes in the brain. To date literature addressing structural
and functional changes in the brain is inconsistent, and lacking proper study
design.
As chronic hyperglycaemia seems a underlying mechanism causing cognitive
changes, the aim of this study is to further investigate the role of
hyperglycaemia to cognition in T1DM. Furthermore, structural and functional
changes in the brain will be investigated, also in relation to chronic
hyperglycaemia.
Study objective
Are changes in cognitive functioning related to structural changes in the brain
in patients with type 1 diabetes mellitus. How are these changes related to
diabetic complications like duration of chronic hypoglycaemia, disease duration
and presence of micro vascular complications.
Study design
Longitudinal study with baseline and follow-up measures.
Study burden and risks
This project will take 10 hours during three visits over 4 years. Participants
are at risk of developing postpunctional headaches.
Van der Boechorststraat 7
1081BT Amsterdam
NL
Van der Boechorststraat 7
1081BT Amsterdam
NL
Listed location countries
Age
Inclusion criteria
For all participants: age: 18-56; right handedness; sufficient knowledge of dutch language; no severe obesity
Exclusion criteria
For all participants: younger than 18/older than 56; left handedness; insufficient knowledge of the Dutch language; psychotropic medication or other conditions affecting both brain structure and functioning
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 | NL22043.029.08 |