Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON56689
Enrollment
84
Registered
2023-12-19
Start date
2024-08-01
Completion date
Unknown
Last updated
2025-09-01

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

Conditions

Diabetes mellitus

Interventions

&nbsp
N/A&nbsp

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 

Design outcomes

Primary

MeasureTime frame
Primary outcome measures are 7T brain MRI microvascular markers, i.e., microvascular reactivity to a visual stimulus, microvascular reactivity to hypercapnia and microvascular blood flow velocity and pulsatility.

Secondary

MeasureTime frame
Secondary outcome measures are 3T brain MRI diffusion tension imaging (a sensitive marker of brain parenchyma damage) and cognitive performance (domain-specific cognitive test battery).

Countries

Netherlands

Contacts

Public ContactT.T. Sloten

Universitair Medisch Centrum Utrecht

t.t.vansloten@umcutrecht.nl088 755 5555

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)