Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01705210 : Functional MRI Biomarkers of Cognitive Decrements in Diabetes
PhaseN/A
AgesMin: 40 Years Max: 75 Years
Eligibility
Inclusion criteria:

- Subjects aged 40-75 years

- Subjects enrolled in the existing 'Maastricht Study' (M-Study)

- Subjects gave written consent to be approached for additional research

- Subjects belongs to the 20% of the worst and 20% of the best performing (as based on
neuropsychological cognitive testing (Stroop color-word test, 15 word learning test,
and Delayed recall and recognition 15 word learning test)

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 [8]:

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

Control participants:

- Those who fulfilled no more than 1 criterium of the metabolic syndrome, no DM2.

Exclusion criteria:

- Contra-indications for MRI examination (e.g. pacemaker; neurostimulator; medication
pump; cochlear or hearing implant; tattoos or other items that cannot be removed and
include metal parts (for instance from operations in the past); metal splinter in the
eye; pregnancy and claustrophobia; brain vessel clamps; denture, which contains
magnets).

- Psychiatric co-morbidity and inability to perform the functional MRI tests.

- Incomplete cognitive assessment data

- Diabetes mellitus type 1 (DM1)

- Subjects who are not belonging to the 20% of the worst and 20% of the best performing
individuals (as based on neuropsychological cognitive testing (Stroop color-word
test, 15 word learning test, and Delayed recall and recognition 15 word learning
test).

- Last visit of the subjects to the M-Study should be less than one year
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01705210      |      Link to official Clinicaltrials.gov listing
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