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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42233

Enrollment

180

Registered

2015-01-26

Start date

2016-05-13

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Genetic variation brain structure cognition

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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 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

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 outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
Genetic biomarkers, including: * SNPs * Heritability * Anthropometrics, cardiovascular function, mental health, lifestyle and risk factors obtained from the Maastricht study database.	—

Countries

Netherlands

Outcome results