Primary Objective: 1) To compare the prevalence en number of microbleeds at 7T between older people with and without DM2, and to relate the lesions to cognitive performanceSecondary Objective(s): 1) To characterize cerebral microinfarcts at 7T and…
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), diabetes status and vascular risk
factors.
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 of these lesions in vivo. Pilot studies have shown that
the prevalence of microbleeds at 7T is 10 times higher than detected with 3T
MR.
Our hypotheses are that
- microvascular lesions, detected at 7T, are more common in patients with DM2
than in aged matched controls
- a higher lesion load is associated with impaired cognition
Study objective
Primary Objective:
1) To compare the prevalence en number of microbleeds at 7T between older
people with and without DM2, and to relate the lesions to cognitive performance
Secondary Objective(s):
1) To characterize cerebral microinfarcts at 7T and to relate these lesions to
DM2 and cognition
2) To relate the microvascular lesions at 7T to conventional imaging markers of
DM2
3) To relate the microvascular lesions at 7T to diabetes status and to diabetes
associated vascular risk factors
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, 1x10ml), a 1.5Tesla and 7Tesla MRI scan of 30 minutes each.
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 | NL29297.041.09 |