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Functional MRI biomarkers of cognitive decrements in diabetes

Functional MRI biomarkers of cognitive decrements in diabetes - Functional MRI in DM2

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON37694
Enrollment
132
Registered
2012-05-16
Start date
2012-09-24
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

brain function cognition

Interventions

None listed

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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 = 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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)