NCT04281186Completed
Retinal and Cognitive Dysfunction in Type 2 Diabetes
Retinal and Cognitive Dysfunction in Type 2 Diabetes: Unraveling the Common Pathways and Identification of Patients at Risk of Dementia
Source: ClinicalTrials.gov · Last updated 12 Mar 2025
Brief summary (registry, in English)
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. This is a multinational and multicentre cross-sectional study and prospective, longitudinal cohort observational study.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 510 (actual)
- First submitted
- 18 Feb 2020
- Start date
- 16 Nov 2020
- Primary completion date
- 12 Dec 2024
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Diseases
- Type 2 diabetes
- NCT number
- NCT04281186
What you commit to
- Study type: Observational
- Participants enrolled: 510
- From 16 Nov 2020 to the primary completion date, 12 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous history of stroke or neurodegenerative diseases.
- Previous laser photocoagulation.
Other illness
- Severe NPDR, Proliferative DR (PDR), Diabetic Macular Edema (DME) or other eye disorders affecting vision besides these complications of diabetic retinopathy (DR).
- Other diseases which may induce retinal neurodegeneration (e.g. glaucoma).
- Severe systemic illness or personal circumstances that would not make it possible for patients to fulfil study protocols.
- Prospective study:
- In addition to the above, participants enrolled in the prospective longitudinal cohort study should fulfilled the following criteria:
- 1\. Established dementia.
Lab values
- HbA1C \> 10% (86 mmol/mol).
Other
- Subjects with a refractive error ≥ ± 6 D.
- Media opacities that preclude retinal imaging.
Who the study is looking for
- Type 2 diabetes
- 65 years and older
- Diabetes duration of at least 5 years
- No overt retinopathy on fundus examination or fundus images, as determined by the evaluating ophthalmologist, in one or both eyes, and people with mild to moderate non-proliferative diabetic retinopathy (NPDR) as determined by the evaluating phthalmologists using fundus examination by slit-lamp biomicroscopy.
- Able to provide informed consent
- Prospective study:
- In addition to the above, participants enrolled in the prospective longitudinal cohort study should fulfilled the following criteria:
- Diagnosis of MCI confirmed by a neuropsychological test battery (NTB) and a specialized physician. For the control group the absence of MCI will also be confirmed by a neuropsychological test battery (NTB) and a specialized physician.
- Diagnosis of no overt or mild to moderate NPDR (ETDRS DR level 20 to 47) confirmed by the reading centre.
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rafael Simó Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.