Primary Objective: 1) To charaterize microbleeds and microinfarcts at 7T, and compare their prevalence in people with and without diabetes, with or without cognitive impairmentSecondary Objective(s): 2) To assess the relevance of the lesions in the…
ID
Source
Brief title
Condition
- Diabetic complications
- Encephalopathies
- Vascular haemorrhagic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The prevalence and total number of microinfarcts and microbleeds at 7T in
relation to DM2 status and cognition.
Secondary outcome
Microvascular lesion load will be related to cognition, conventional MR markers
(atrophy, white matter hyperintensities), vascular and metabolic risk factors,
brain connectivity parameters and cerebral blood flow.
Background summary
Type 2 diabetes (DM2) is associated with cognitive decrements and an increased
risk of dementia. Further insight in the natural history and etiology of these
decrements is required to optimize treatment. We aim to identify novel brain
imaging correlates of impaired cognition in DM2, which may serve as a surrogate
outcome measure in future intervention studies.
Neuropathological studies identify microvascular lesions, i.e. microinfarcts
and microbleeds, as important correlates of impaired cognition in older
individuals, but these lesions go largely undetected on conventional MR
imaging. The introduction of high field strength clinical MR scanners now
enables the detection these lesions in vivo. Our hypotheses are that
• microvascular lesions are more common in patients with DM2 and can be
detected with high resolution magnetic MR imaging at high field strength (7
Tesla)
• a higher lesion load is associated with impaired cognition, both in older
individuals with and without DM2
Study objective
Primary Objective:
1) To charaterize microbleeds and microinfarcts at 7T, and compare their
prevalence in people with and without diabetes, with or without cognitive
impairment
Secondary Objective(s):
2) To assess the relevance of the lesions in the context of DM2:
- The occurrence of microbleeds and microinfarcts at 7T will be related to
other imaging markers of DM2, including WMH volume and diffusion tensor imaging
(DTI).
- The occurrence of microbleeds and microinfarcts at 7T will be related to
cerebral perfusion and to the presence of metabolic and vascular risk factors
3) To assess the relevance of the lesions in older individuals without DM2
Study design
This is an observational cross-sectional population-based study
Study burden and risks
Approximately 600 eligible individuals will undergo a short telephone interview
including a cognitive screening test (10 min). Based on the interview 140
individuals will be visited at home for a detailed neuropsychological
assessment (1 hour). From this group, 112 will be selected for a visit to the
UMC Utrecht. The visit includes a medical examination (30 min) in which blood
is drawn (3x5ml), a 1.5Tesla and 7Tesla MRI scan of 30 minutes each and
photograph of the retina. There are no health risks associated with the
procedures and techniques used.
Heidelberglaan 100, postbus 85500
3508 GA Utrecht
Nederland
Heidelberglaan 100, postbus 85500
3508 GA Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
age between 65 and 80 years
diabetes patients: diagnosed with diabetes for more than 1 year
Exclusion criteria
- Dementia
- TIA or non-invalidating stroke in the past 2 years or any invalidating stroke.
- Other neurological diseases, unrelated to DM2, that are likely to affect cognition, including a history of brain trauma requiring hospitalisation
- Known with or history of psychiatric disorders requiring hospitalisation or >12 months medication use (e.g. schizophrenia , Major depression (DSM IV))
- Contra-indication for 7 Tesla MR imaging (as established by the department)
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 | NL27076.041.09 |