Functional MRI biomarkers of cognitive decrements in diabetes

Recruiting

Conditions: brain function
cognition
10012653
10042258

Registration Number: NL-OMON37694

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 132

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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1) To tailor and apply multi-parametric, functional MRI techniques to identify<br /><br>cerebral abnormalities (cerebral biomarkers) in DM2 and MetS.<br /><br>2) To investigate which cerebral biomarkers are shared and differ between DM2<br /><br>and MetS.<br /><br>3) To assess whether these cerebral biomarkers are associated with cognitive<br /><br>decrements in DM2 and MetS.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) To determine whether these neuronal biomarkers are associated with<br /><br>anthropometrical and cardiovascular characteristics.<br /><br>2) To evaluate which MRI technique is most sensitive for detecting cerebral<br /><br>abnormalities. </p><br>