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Impact of diabetic retinopathy and neuropathy on cognition, visual perception, retinal microvasculature and neuroinflammatory biomarker in type II diabetes mellitus

Role of diabetic retinopathy including chorioretinal microvasculature and diabetic neuropathy including neuroinflammatory biomarker on cognition and visual perception in type II diabetes mellitus

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/10/076002
Enrollment
168
Registered
2024-10-28
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H352- Other non-diabetic proliferative retinopathy

Interventions

None listed

Sponsors

Ms Preethi Naik
Lead Sponsor
Applied for ICMR small extramural grants Proposal Id IIRPSG
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Type II Diabetes Mellitus: 1. Those who write and read in Kannada/ English 2. Type-2 DM minimum period of condition for one year 3. Best corrected visual acuity (BCVA) better than 6/12 for distance and near N6 at 40cm Diabetic Retinopathy: 1. Those who write and read in Kannada/ English 2. Presence of type 2 DM minimum duration of condition for one year with the diabetic retinopathy 3. BCVA better than 6/12 for distance and near N6 at 40cm Diabetic Neuropathy: 1. Those who write and read in Kannada/English 2. Presence of type 2 DM minimum duration of condition for one year with the diabetic neuropathy 3. BCVA better than 6/12 for distance and near N6 at 40cm Age-matched normal: 1. Those who write and read in Kannada/English 2. Those who are non-diabetic 3. BCVA better than 6/12 for distance and near N6 at 40cm

Exclusion criteria

Exclusion criteria: Type II Diabetes Mellitus: 1. History of glaucoma, Age-related macular degeneration, hypertensive retinopathy 2. Individuals who have Neurological disorders, Parkinson’s disease, psychiatric conditions, Alzheimer’s disease, and Cerebrovascular disease 3. Presence of diabetic neuropathies and diabetic retinopathy Diabetic Retinopathy: 1. History of glaucoma, Age-related macular degeneration, hypertensive retinopathy 2. Individuals who have Neurological disorders, Parkinson’s disease, psychiatric conditions, Alzheimer’s disease, and Cerebrovascular disease 3. Presence of diabetic neuropathies Diabetic Neuropathy: 1. History of glaucoma, Age-related macular degeneration, hypertensive retinopathy 2. Individuals who have Neurological disorders, Parkinson’s disease, psychiatric conditions, Alzheimer’s disease, and Cerebrovascular disease 3. Presence of diabetic retinopathy Age-matched normal: 1. History of glaucoma, Age-related macular degeneration, hypertensive retinopathy 2. Individuals who have Neurological disorders, Parkinson’s disease, psychiatric conditions, Alzheimer’s disease, and Cerebrovascular disease 3. No retinal changes

Design outcomes

Primary

MeasureTime frame
• Cognitive functions will be evaluated by using MoCA – total scores of MoCA will be noted • Visual perception will be assessed by using the Motor free visual perceptual skills test (MVPT-4) – Raw score of MVPT will be noted • Retinal nerve fiber layer thickness in µm • Vessel density in percentage • Foveal avascular zone area in mm2 • Avascular density in percentage • Blood biomarkers - Neurofilament light chain (NFL), Glycated Haemoglobin, lipid profile, C-PeptideTimepoint: 48 months

Secondary

MeasureTime frame
• Cognitive functions will be evaluated by using MoCA – total scores of MoCA will be noted • Visual perception will be assessed by using the Motor free visual perceptual skills test (MVPT-4) – Raw score of MVPT will be noted • Retinal nerve fiber layer thickness in µm • Vessel density in percentage • Foveal avascular zone area in mm2 • Avascular density in percentage • Blood biomarkers - Neurofilament light chain (NFL), Glycated Haemoglobin, lipid profile, C-PeptideTimepoint: 48 months

Countries

India

Contacts

Public ContactPreethi Naik

Kasturba Medical College Manipal Academy of Higher Education

yogish.kamath@manipal.edu9845308436

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026