Is the presence and development of microvascular disease in type 1 diabetes related to changes in brain structure and cognitive function?

Completed

Conditions: abnormalities of the small blood vessels inside the brain and the relationship with attention
concentration and memory
Microvascular disease of the brain and cognitive functioning
10012653
10007963

Registration Number: NL-OMON29744

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 150

Inclusion Criteria

age 18-45 years
right-handedness:
Dutch as a native language

Exclusion Criteria

alcohol abuse which is defined as more than 20 gram of alcohol per day,
(history of) use of MDMA, cocaine, heroin, methylphenidate, current regular use of cannabis, or history of regular use on a daily basis for at least 5 years,
current use of benzodiazepines, non-selective beta blockers, oral steroids (>7.5 mg/day),
psychiatric disorder warranting psychotropic treatment (e.g. tranquillisers, anti-depressants)
anaemia or thyroid dysfunction,
history of severe head trauma accompanied by loss of consciousness,
stroke
epilepsy
pregnancy
Parkinson*s disease
inability to undergo MRI (claustrophobia, metal implants, BMI>35),
visual acuity < 0.3 at the last ophthalmologic examination
diabetes duration < 10 years
all other factors that can possibly contribute to cognitive decline or altered cerebral blood flow

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint:<br /><br>Cognitive function (neuropsychological performance, specifically attention,<br /><br>mental flexibility and executive functioning) at baseline and at follow-up<br /><br></p><br>

Secondary Outcome Measures