Last reviewed · How we verify

NCT04610749: DIRMA

Diabetic Retinopathy as a Marker of Cognitive Dysfunction and Depression

Completed Last updated 4 April 2022
What this trial tests

trial in Diabetic Retinopathy in 148 participants. Completed in 25 February 2022.

Timeline
25 November 2020
Primary endpoint
25 February 2022
25 February 2022

Quick facts

Lead sponsorRegion of Southern Denmark
StatusCompleted
Study typeOBSERVATIONAL
Enrollment148
Start date25 November 2020
Primary completion25 February 2022
Estimated completion25 February 2022
Sites1 location across Denmark

Conditions studied

Sponsor

Region of Southern Denmark

Who can join

65 and older, any sex, with Diabetic Retinopathy or Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In recent years damage to the nerve fibers in the retina has been experienced as an early sign of complications resulting from type 2 diabetes. In addition, it has been presented that people with type 2 diabetes are at increased risk of developing brain diseases, such as mild memory impairment and Alzheimer's disease, as well as mental illness in the form of depression. The eye corresponds to be a protruding part of the brain which means the brain and the eye share common features. Currently it is time and cost consuming to asses changes in the brain, but recent research has shown that patient friendly eye examinations can detect nerve loss brain diseases. Recent studies have shown that depression can also have a physiological component, which can be measured by changes in structures in the retina of the eye. In this research project, we will conduct a clinical study, to assess whether there is an association between changes in the retina of the eye (e.g. vascular structure, retinal thickness and oxygen saturation) and mild memory impairment and depression respectively in people with type 2 diabetes. The clinical study will help to clarify the possibility of including patient-friendly eye examinations in the assessment of minimal memory impairment and depression in patients with type 2 diabetes. 200 people with type 2 diabetes will be invited to participate in a clinical cross-sectional study. The Funen Diabetes Database will be used as recruitment tool. Participants will undergo a thorough eye examination as well as neuropsychological examinations for signs of mild memory impairment. They will also complete questionnaires regarding depressive symptoms. Overall, the research project will help to create awareness in this area among both healthcare professionals and patients. Early risk detection could mean better diabetes care and fewer complications, which will have a major impact on quality of life and contribute to socio-economic gains. Any findings may contribute to the discussion of individualized screening and treatment if some individuals within this group are at increased risk of developing memory impairment or depression.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Associations between metabolic and structural retinal parameters and depression in individuals with type 2 diabetes.
    Pedersen FN, Stokholm L, Lois N, Yang D, et al · · 2026 · PMID 41593780 · DOI 10.1186/s40942-026-00800-x

Verify or expand the search:

Other recruiting trials for Diabetic Retinopathy

Currently open trials in the same condition.

Other Region of Southern Denmark trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04610749.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing