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Early detection of cognitive decline in diabetes mellitus with a eye tracking test

Early detection of cognitive decline in diabetes mellitus with a eye tracking test

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400089279
Enrollment
Unknown
Registered
2024-09-05
Start date
2024-09-09
Completion date
Unknown
Last updated
2024-09-09

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

Conditions

Type II diabetes

Interventions

Gold Standard:Neuropsychological Assessment Scale, biomarkers, imaging.
Index test:Montreal Cognitive Assessment,mini-mental state examination,Eye-tracking data,Differential gene analysis

Sponsors

Zhejiang Rehabilitation Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Meeting the diagnostic criteria for the Chinese Guidelines for the Prevention and Control of Type 2 Diabetes Mellitus (2022 edition): (1) Fasting plasma glucose =7.0 mmol/L (confirmed by repeat testing on a subsequent day in the absence of unequivocal hyperglycemia symptoms) (2) Classic symptoms of diabetes (polydipsia, polyuria, polyphagia, unexplained weight loss) + random plasma glucose or venous plasma glucose =11.1 mmol/L; (3) 2-hour plasma glucose during 75g oral glucose tolerance test (OGTT) =11.1 mmol/L (confirmed by repeat testing on a subsequent day in the absence of unequivocal hyperglycemia symptoms); (4) Glycated hemoglobin (HbA1c) =6.5% 2. MMSE score =17 (no education), =20 (1-6 years of education), =24 (more than 7 years of education), and MoCA score =13 (no education), =19 (1-6 years of education), =24 (more than 7 years of education); report cognition impairment by themselves, family members and doctor. 3. Normal people without psychiatric or neurological disorders, with normal cognitive functioning and MMSE scores greater than 25.

Exclusion criteria

Exclusion criteria: Organic lesions in the brain (such as brain tumors, cerebral infarction, hemorrhage, or vascular malformations); history of epilepsy, traumatic brain injury, and craniotomy; history of mental disorders (such as depression, schizophrenia, etc.); systemic organic diseases (such as uremia, etc.) or history of extracranial tumors; moderate to severe hypertension (systolic blood pressure =160 mmHg or diastolic blood pressure =100 mmHg), glaucoma, high myopia, and other conditions that prevent the completion of eye movement experiments.

Design outcomes

Primary

MeasureTime frame
Montreal Cognitive Assessment;Mini-mental state examination;

Secondary

MeasureTime frame
Staring time;Saccade count;Saccade amplitude;Saccade frequency;Search time;

Countries

China

Contacts

Public ContactGao Yuan

Zhejiang Rehabilitation Medical Center

gaoacu@sina.com+86 138 1720 5124

Outcome results

None listed

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