Primary objectives: 1.1) To investigate to what extent the different functions of the cerebral microvasculature are impaired in type 1 diabetes; and 1.2) To investigate to what extent the different functions of the cerebral microvasculature are…
ID
Source
Brief title
Condition
- Diabetic complications
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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).
Background summary
Individuals with type 1 and type 2 diabetes have a two times higher risk of
dementia. However, prevention of dementia in diabetes beyond conventional
management has been unsatisfactory, likely because the underlying mechanisms
are unknown. We propose that cerebral microvascular dysfunction is a key
mechanism underlying dementia in both type 1 and type 2 diabetes. Experimental
data indicate that the cerebral microvasculature has many functions that, when
impaired, can lead to brain damage and contribute to dementia. However, data in
human diabetes on cerebral microvascular dysfunction are largely missing.
Study objective
Primary objectives: 1.1) To investigate to what extent the different functions
of the cerebral microvasculature are impaired in type 1 diabetes; and 1.2) To
investigate to what extent the different functions of the cerebral
microvasculature are impaired in type 2 diabetes. Secondary objectives: 2.1) To
investigate the association between cerebral microvascular dysfunction and
brain parenchyma damage; and 2.2) To investigate the association between
cerebral microvascular dysfunction and domain-specific cognitive performance
Study design
Cross-sectional nested case-control study.
Study burden and risks
The burden associated with participation is that participants will come to the
UMC Utrecht to receive a brain MRI and a cognitive test battery. This will be
an extra study visit next to the study visit for the other measurements in
SMART. There is no direct personal benefit for the enrolled participants.
Benefits in term of knowledge are potentially very valuable as the study
findings will improve our understanding of cerebral microvascular
pathophysiology. This will ultimately help to identify targetable factors for
prevention of diabetes-related dementia. Risks are small, because there are no
known risks associated with the MRI acquisition
Heidelberglaan 100 100
Utrecht 3508GA
NL
Heidelberglaan 100 100
Utrecht 3508GA
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL85830.041.23 |