The primary objectives are defined according to a hierarchical design: i) to tailor and apply multi-parametric, functional MRI techniques to identify cerebral abnormalities (cerebral biomarkers) in DM2 and MetS; ii) to investigate which cerebral…
ID
Source
Brief title
Condition
- Diabetic complications
- Structural brain disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) To tailor and apply multi-parametric, functional MRI techniques to identify
cerebral abnormalities (cerebral biomarkers) in DM2 and MetS.
2) To investigate which cerebral biomarkers are shared and differ between DM2
and MetS.
3) To assess whether these cerebral biomarkers are associated with cognitive
decrements in DM2 and MetS.
Secondary outcome
1) To determine whether these neuronal biomarkers are associated with
anthropometrical and cardiovascular characteristics.
2) To evaluate which MRI technique is most sensitive for detecting cerebral
abnormalities.
Background summary
Diabetes mellitus type 2 (DM2) is a common chronic metabolic disorder that
affects 4.1% of the Dutch population. In addition to vascular disease, DM2 is
associated with structural brain changes visible on MRI, accelerated cognitive
decline, and dementia in older individuals. The exact pathophysiological
mechanisms underlying cognitive decrements in DM2 still remain to be
elucidated. The *metabolic syndrome* (MetS), defined as a cluster of
cardiovascular risk factors (including obesity, hypertension, and dyslipidemia)
is often considered a prediabetic condition. Individuals with MetS display
similar cognitive decrements as do DM2 patients, but do not share the severity
of brain injury. It has been indicated that in prediabetic MetS, cognitive
problems precede structural brain changes, and that MetS and DM2 affect the
brain through a shared mechanism in which vascular co-morbidity is essential.
Study objective
The primary objectives are defined according to a hierarchical design: i) to
tailor and apply multi-parametric, functional MRI techniques to identify
cerebral abnormalities (cerebral biomarkers) in DM2 and MetS; ii) to
investigate which cerebral biomarkers are shared and differ between DM2 and
MetS; iii) to assess whether these cerebral biomarkers are associated with
cognitive decrements.
Study design
Cross-sectional observational study design
Study burden and risks
The burden for participants is restricted to 30 minutes preparation / aftercare
and one MRI scan session of approximately 60 minutes. All the measurements are
non-invasive and participants with contra-indications for MRI will be excluded.
Therefore the risks associated with participating in this study are negligible.
There is a small risk that we detect an incidental finding. In case of
significant incidental findings, the general practitioner or relevant
specialist will be informed. Consequently, the participant is contacted by
telephone within four weeks.
P. Debyelaan 25
6202 AZ Maastricht
NL
P. Debyelaan 25
6202 AZ Maastricht
NL
Listed location countries
Age
Inclusion criteria
General:
subjects aged 40-75 years, subjects enrolled in the existing 'Maastricht Study', Subjects gave written consent to be approached for additional research, subjects belong to the 20% of the worst and 20% of the best performing (as based on neuropsychological cognitive testing) individuals.;Diabetes type 2:
fasting blood glucose >= 7.0 mmol/l, after an oral glucose tolerance test (OGTT) blood glucose >= 11.1 mmol/l or used oral glucose-lowering medication or insulin.;Metabolic Syndrome:
Participants should meet three out of 5 of the following criteria:
1. Waist circumference > 88 cm (women), > 102 cm (men)
2. Triglycerides >= 1.7 mmol/l
3. HDL cholesterol < 1.3 mmol/l (women), < 1.0 mmol/l (men)
4. Blood pressure >= 130/85 mmHg (or medication)
5. Fasting blood glucose >= 6.1 mmol/l, after an OGTT blood glucose >= 7.8 mmol/l;Healthy controls:
Who fulfilled no more that 1 criterium of the metabolic syndrome, no Diabetes type 2.
Exclusion criteria
Contra-indications for MRI examination:
1) pacemaker, 2) neurostimulator, 3) medication pump, 4) cochlear or hearing implant, 5) tattoos or other items that cannot be removed and include metal parts, 6) metal splinter in the eye, 7) pregnancy, 8) claustrophobia, 9) brain vessel clamps, 10) denture, which contains magnets, 11) operations in the past, where metal or synthetic material is used and still were in the body ;Psychiatric comorbidity and inability to perform the functional MRI tests.
Diabetes mellitus type 1 (DM1)
Subjects who are not belonging to the 20% of the worst and 20% of the best performing individuals
Last visit of the subjects to the M-Study should be less than one year
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 | NL38511.068.11 |