High-field (7T) MRI and genetic biomarkers for neurocognitive impairment in type 2 diabetes melltius

Completed

• Conditions: Genetic variation; brain structure; cognition; 10018424; 10042258

• Registration Number: NL-OMON42233
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 180

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).

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>MRI Biomarkers of brain alterations, including:<br /><br>* Quantitative measures (T1/T2* relaxation time maps),<br /><br>* Cerebral blood flow (arterial spin labeling, ml blood/100 g tissue/min),<br /><br>* Functional characteristics (in resting state or during a task),<br /><br><br /><br>Cognitive functioning z-scores based on different domains:<br /><br>* Verbal memory<br /><br>* Attention and flexibility<br /><br>* Executive functioning<br /><br>* Fluency<br /><br>* Psychomotor speed<br /><br>* General cognitive function</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Genetic biomarkers, including:<br /><br>* SNPs<br /><br>* Heritability<br /><br><br /><br>* Anthropometrics, cardiovascular function, mental health, lifestyle and risk<br /><br>factors obtained from the Maastricht study database.</p><br>