Retinal and Cognitive Dysfunction in Type 2 Diabetes

NCT04281186 | Completed

• 1 other identifier: ECR-RET-2019-14
• Study Type: observational
• Target: 510
• Locations: 1 country
• Sites: 1

Brief 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. This is a multinational and multicentre cross-sectional study and prospective, longitudinal cohort observational study.

Conditions

Retinal Function; Cognitive Dysfunction; Microperimetry

Outcome Measures

Primary Outcomes (1)

• Retinal sensitivity

  Assessed by microperimetry

  48 month

Secondary Outcomes (12)

• Retinal neurodysfunction/ neurodegeneration-1

  48 month

• Retinal neurodysfunction/ neurodegeneration-2

  48 month

• Retinal neurodysfunction/ neurodegeneration-3

  48 month

• Retinal vascular abnormalities-1

  48 month

• Retinal vascular abnormalities-2

  48 month

Study Arms (3)

Cross-sectional cohort

Up to 720 type 2 diabetic patients (\>5 years duration), older than 65 years of age are expected to be recruited in orfer to asure the sample of 168 patients with MCI and 63 normocognitive fulfilling criteria for the prospective study.

Prospective study-MCI

Target 168 Patients from the cross-sectional cohort diagnosed with mild cognitive impairment during the cross-sectional evaluation

Prospective study normocognitive

63 Patients from the cross-sectional cohort without mild cognitive impairment evaluated during the cross-sectional evaluation

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with type 2 diabetes, older than 65 years of age.

You may qualify if:

• Type 2 diabetes
• 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.

You may not qualify if:

• Previous history of stroke or neurodegenerative diseases.
• Severe NPDR, Proliferative DR (PDR), Diabetic Macular Edema (DME) or other eye disorders affecting vision besides these complications of diabetic retinopathy (DR).
• Previous laser photocoagulation.
• Other diseases which may induce retinal neurodegeneration (e.g. glaucoma).
• Subjects with a refractive error ≥ ± 6 D.
• Media opacities that preclude retinal imaging.
• HbA1C \> 10% (86 mmol/mol).
• 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:
• \. Established dementia.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead
• Queen's University, Belfast: collaborator
• Association for Innovation and Biomedical Research on Light and Image: collaborator
• UMC Utrecht: collaborator
• University of Medical Centre Amsterdam: collaborator
• University of Rome Tor Vergata: collaborator
• Ospedale San Raffaele: collaborator
• University of Milan: collaborator
• University of Southern Denmark: collaborator
• Azienda Ospedaliero Universitaria Maggiore della Carita: collaborator
• Hospital Mutua de Terrassa: collaborator
• Institut Catala de Salut: collaborator
• University of Montenegro: collaborator
• Clinical Center of Montenegro: collaborator
• University of Cadiz: collaborator
• European Infrastructure for Translational Research: collaborator
• Alzheimer Europe: collaborator
• International Diabetes Federation Europe: collaborator
• Anaxomics Biotech S.L.: collaborator
• Oxurion: collaborator
• Genesis Biomed: collaborator

Study Sites (1)

Rafael Simó

Barcelona, 08035, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Noemi Lois, Prof.

  Queen´s University Belfast

  STUDY DIRECTOR

• Rafael Simó, Prof

  Vall Hebron Research Institute-VHIR

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Rafael Simo Canonge

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 24, 2020
• Study Start: November 16, 2020
• Primary Completion: December 12, 2024
• Study Completion: December 31, 2024
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

ES (1)