Retinal and cognitive dysfunction in type 2 diabetes: unraveling the common pathways and identification of patients at risk of dementia.

Recruiting

Conditions: cognitieve toestand
cognitive impairment
type 2 diabetes
10047060

Registration Number: NL-OMON55006

Lead Sponsor: Fundació Hospital Universitari Vall DHebron - Institut de Recerca, VHIR

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 35

Inclusion Criteria

1. Diagnosis of mild to moderate nonproliferative diabetic retinopathy (ETDRS
DR level 20
to 47) confirmed by the reading centre or with no overt retinopathy.
2. Diagnosis of MCI confirmed by a neuropsychological test battery (NTB), CDR
and a specialized physician or a neuropsychologist. For the control group the
absence of MCI will also be confirmed by a NTB and a specialized physician or a
neuropsychologist.

Exclusion Criteria

1. Major depression (GDS-15 = 9)
2. Established dementia

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Retinal sensitivity assessed by microperimetry</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>a. Retinal variables:<br /><br>- Retinal neurodysfunction/ neurodegeneration assessed by gaze fixation<br /><br>(microperimetry), Full-field photopic electriretinogram (ERG) and Spectral<br /><br>Domain Optical Coherence Tomography (SDOCT).<br /><br>- Vascular abnormalities assessed by Optical Coherence Tomography Angiography<br /><br>(OCT-A), and Ultra-wide field Fundus Fluorescein Angiography (FFA).<br /><br>b. Brain imaging assessed by Magnetic Resonance Imaging (MRI) and 18<br /><br>Fluoro-2-deoxyglucose-Positron Emission Tomography (18FDG-PET).<br /><br>c. Circulating biomarkers<br /><br>d. Other: Geriatric Depression Scale (GDS-15), EQ-5D-3L questionnaire, 25-item<br /><br>National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) and<br /><br>Diabetes Specific Dementia Risk Score (DSDRS).</p><br>