Microvasculature-brain interaction in diabetes: an ultrahigh field MRI study

Conditions: Diabetes mellitus
sugar disease
10012653
10007963

Registration Number: NL-OMON56689

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 84

Inclusion Criteria

- Age 50 years or older
- Understanding of the Dutch language

- For the diabetes subgroups: participation in UCC-SMART and diabetes mellitus,
defined as a self-reported history of diabetes, use of oral glucose-lowering
medication or insulin, or a fasting serum glucose concentration of >=7 mmol/L at
study inclusion.
o Type 1 diabetes: diabetes in individuals who immediately needed insulin at
onset and absence of oral glucose lowering medication.
o Type 2 diabetes: diabetes in individuals with a self-reported history of type
2 diabetes, with a referral diagnosis of type 2 diabetes, or use or oral
glucose-lowering medication
- For controls, we will include age- and sex-matched controls without diabetes
who have not been included in UCC-SMART.

Exclusion Criteria

- Diabetes other than type 1 or type 2, e.g., maturity onset diabetes of youth,
gestational diabetes or diabetes due to pancreatic disease
- Prediabetes
- Any general contra-indication for brain MRI, i.e., metallic objects in or
around the body (e.g., cardiac implantable electronic device such as pacemakers
and implantable cardioverter defibrillators), claustrophobia or pregnancy
- Other major neurological or psychiatric conditions affecting the brain and
interfering with the study design, e.g., multiple sclerosis, epilepsy,
Parkinson*s disease, prior stroke or vascular dementia
- Other factors that may limit the interpretation of the study results, i.e.,
uncontrolled hypertension (defined as systolic or diastolic blood pressure
>160/110 mmHg with or without use of antihypertensive medication), current
smoking or BMI >40 kg/m2

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome measures are 7T brain MRI microvascular markers, i.e.,<br /><br>microvascular reactivity to a visual stimulus, microvascular reactivity to<br /><br>hypercapnia and microvascular blood flow velocity and pulsatility.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures are 3T brain MRI diffusion tension imaging (a<br /><br>sensitive marker of brain parenchyma damage) and cognitive performance<br /><br>(domain-specific cognitive test battery). </p><br>