To determine whether functional and/or structural retinal biomarkers or circulating biomarkers are able to differentiate people with mild cognitive impairment (MCI) within the type 2 diabetes (T2D) population (this we will be able to do in the…
ID
Source
Brief title
Condition
- Other condition
- Retina, choroid and vitreous haemorrhages and vascular disorders
Synonym
Health condition
cognitief functioneren
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess whether retinal sensitivity measured by microperimetry is able to
predict cognitive decline and progression to dementia in MCI T2D patients.
Secondary outcome
1) To assess whether retinal sensitivity, measured by microperimetry, can
identify individuals with MCI among people with T2D.
2) To assess whether eye fixation, measured by microperimetry, can identify
individuals with MCI among people with T2D.
3) To assess whether eye fixation measured by microperimetry is able to predict
rapid cognitive decline in T2D patients with MCI.
4) To define a T2D phenotype at high risk of developing dementia based on
retinal imaging and functional retinal assessments.
5) To determine whether retinal imaging and functional retinal assessments may
identify individuals with MCI among people with T2D.
6) To define a T2D phenotype at high risk to develop cognitive decline and
dementia based on retinal imaging plus brain imaging.
7) To define a T2D phenotype at high risk to develop dementia based on retinal
imaging plus brain imaging plus circulating biomarkers.
8) To establish a score to predict cognitive decline or progression from MCI to
dementia based on the variables included in the study.
Background summary
The retina shares similar embryologic origin, anatomical features and
physiological properties with the brain and hence offers a unique and
accessible *window* to study the correlates and consequences of subclinical
pathology in patients with cognitive impairment. Our hypothesis is that the
neurodegeneration of the retina will run in parallel to the neurodegeneration
of the brain and, therefore, the signs of neurodysfunction in the retinal
assessment will be more evident in those patients with rapid cognitive decline.
Microangiopathy will also participate in cognitive decline and its specific
role, as well as usefulness of retinal imaging, will be also examined.
Study objective
To determine whether functional and/or structural retinal biomarkers or
circulating biomarkers are able to differentiate people with mild cognitive
impairment (MCI) within the type 2 diabetes (T2D) population (this we will be
able to do in the crosssectional study, and, thus, use retina and/or blood
biomarkers as a potential proxy to events taking place in the brain).
Study design
This is a multinational and multicentre cross-sectional study.
Study burden and risks
Disadvantages of participating in the study may be
- possible discomfort during the blood test in the studie
- spending more time
- extra hospital visits
- additional tests
Benefit of participating in the study may be
- more testing and research. These can pinpoint any issues that would otherwise
have gone unnoticed to more advanced stages.
Passeig Vall dHebron, Edificio De Recerca 119-129
Barcelona 08035
ES
Passeig Vall dHebron, Edificio De Recerca 119-129
Barcelona 08035
ES
Listed location countries
Age
Inclusion criteria
1. Type 2 diabetes
2. 65 years and older
3. Diabetes duration of at least 5 years
4. Mild to moderate non-proliferative diabetic retinopathy (NPDR) or with no
overt retinopathy
5. Able to provide informed consent
Exclusion criteria
1. Previous history of stroke or neurodegenerative diseases
2. Severe NPDR, Proliferative DR (PDR), Diabetic Macular Edema (DME) or other
eye disorders affecting vision besides these complications of DR
3. Previous laser photocoagulation
4. Other diseases which may induce retinal neurodegeneration (e.g. glaucoma).
5. Subjects with a refractive error = ± 6 D.
6. Media opacities that preclude retinal imaging
7. HbA1C > 10% (86 mmol/mol)
8. Severe systemic illness or personal circumstances that would not make it
possible for the patients to fulfil study protocols
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 |
|---|---|
| ClinicalTrials.gov | NCT04281186 |
| CCMO | NL74408.018.20 |