The primary objectives: 1. To tailor and apply high-field multi-parametric and functional MRI techniques to identify cerebral biomarkers in DM2 and MetS patients compared to control subjects.2. To examine a specific set of genetic hypotheses in DM2…
ID
Source
Brief title
Condition
- Other condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Structural brain disorders
Synonym
Health condition
Genetic variation
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
MRI Biomarkers of brain alterations, including:
* Quantitative measures (T1/T2* relaxation time maps),
* Cerebral blood flow (arterial spin labeling, ml blood/100 g tissue/min),
* Functional characteristics (in resting state or during a task),
Cognitive functioning z-scores based on different domains:
* Verbal memory
* Attention and flexibility
* Executive functioning
* Fluency
* Psychomotor speed
* General cognitive function
Secondary outcome
Genetic biomarkers, including:
* SNPs
* Heritability
* Anthropometrics, cardiovascular function, mental health, lifestyle and risk
factors obtained from the Maastricht study database.
Background summary
Type 2 diabetes mellitus (DM2) is a common chronic metabolic disorder
characterized by high blood glucose (i.e. hyperglycemia). In
addition to vascular disease, DM2 is associated with structural brain changes
visible on MRI, accelerated cognitive decline and dementia in older
individuals. The progression of normal glucose metabolism to DM2 is a gradual
process in which insulin resistance plays a crucial role. Insulin resistance,
before the clinical presentation with DM2, is often accompanied by other
metabolic and vascular abnormalities which is known as the metabolic syndrome
(MetS). Individuals with MetS display similar cognitive decrements as do DM2
patients, but do not share the severity of brain injury. It is known that
progression to DM2 results from the interaction of environmental factors with a
set of genetic variants. Identifying genetics variants and MRI biomarkers that
could predict cognitive decline in DM2 may enable enhancement of DM2-related
healthcare by improving treatment and/or (more intensive) precautious
strategies.
Study objective
The primary objectives:
1. To tailor and apply high-field multi-parametric and functional MRI
techniques to identify cerebral biomarkers in DM2 and MetS patients compared to
control subjects.
2. To examine a specific set of genetic hypotheses in DM2 and MetS subjects
compared to control subjects
3. To explore the relationship between both cerebral biomarkers and genetic
differences to cognitive functioning in DM2 and MetS patients.
The secondary objectives:
1. To determine whether these cerebral biomarkers are associated with
anthropometrical and cardiovascular characteristics.
2. To evaluate which MRI technique is most sensitive for detecting cerebral
abnormalities
Study design
Cross-sectional observational study design
Study burden and risks
The burden for participants is restricted to 30 minutes preparation/aftercare,
one high-field (7T) MRI scan session of approximately 60 minutes. All
measurements are non-invasive and participants with contraindications for MRI
will be excluded. Therefore the risks associated with participating in this
study are negligible. In case of unexpected medical findings, the participant
and the general practitioner of the participant will be informed. With regards
to the genetic data, results will not be communicated to the subjects as these
are considered not relevant for diagnosis or increased risk
Oxfordlaan 55
Maastricht 6229 EV
NL
Oxfordlaan 55
Maastricht 6229 EV
NL
Listed location countries
Age
Inclusion criteria
General:
* Aged 40-75
* Enrolled in existing *Maastricht Study* (M-Study)
- Complete dataset available
- Completed all four visits (including 3T MRI scan)
* Gave written informed consent to the M-Study board to be approached for additional research;DM2:
* Fasting blood glucose * 7.0 mmol/l, or
* After an oral glucose tolerance test (OGTT) blood glucose * 11.1 mmol/l or
* Used oral glucose-lowering medication or insulin;MetS:
* Impaired glucose metabolism (IGM) with fasting blood glucose * 6.1 mmol/l or after an OGTT blood glucose * 7.8 mmol/l;In addition, participants should meet two out of 4 of the following criteria [35]:
* Triglycerides * 1.7 mmol/l
* HDL cholesterol < 1.3 mmol/l (women), < 1.0 mmol/l (men)
* Blood pressure * 130/85 mmHg (or medication)
* Waist circumference > 88 cm (women), > 102 cm (men);For age and gender matched controls:
* No IGM and no more than 1 criterion of the metabolic syndrome
* No DM2
* No cognitive impairment (MMSE score > 24)
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 or other disorders likely to impact on informed consent;
* Diabetes mellitus type 1 (DM1).
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 | NL51219.068.14 |