Cognitive decline and brain structural alterations caused by metabolic dysfunction in older adults with type 2 diabetes: a prospective observational study.

Cognitive decline and brain structural alterations caused by metabolic dysfunction in older adults with type 2 diabetes: a prospective observational study. - Cognitive decline and brain structural alterations caused by metabolic dysfunction in older adults with type 2 diabetes: a prospective observational study.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000042181

Enrollment

200

Registered

2020-10-26

Start date

2020-11-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Older adults with type 2 diabetes mellitus.

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects who 1) are diagnosed with type 2 diabetes mellitus. 2) aged 65-85 at the time of enrollment. 3) have no or mild impairment of basic activities of daily living (Barthel Index >= 80). 4) have Japanese version of Montreal Cognitive Assessment [MoCA-J] score of 17-30. 5) have provided a written informed consent on this study and biobank project by subjects.

Exclusion criteria

Exclusion criteria: Subjects who 1) are diagnosed with type 1 diabetes mellitus. 2) are diagnosed with dementia. 3) are unable to perform cognitive tests. 4) use implanted medical devices, such as pacemakers. 5) decreased cognitive function due to Parkinson's disease, apoplexy, Huntington's disease, normal pressure hydrocephalus, brain tumors, progressive supranuclear palsy, corticobasal degeneration, multiple system atrophy, aphasia, epilepsy, subdural hematoma, encephalitis/meningitis, multiple sclerosis, or head injury. 6) have any local lesion, such as cerebral infarction(s) detected by CT or MRI before enrollment, that may greatly affect cognitive function. 7) have a history of major depression, bipolar disorder, schizophrenia, or alcohol/drug abuse; have current serious or unstable disease. 8) unsuitable for treatment due to vitamin B1/B12 and/or folate deficiency, or thyroid dysfunction 9) are deemed ineligible for enrollment by the responsible researcher or co-researcher.

Design outcomes

Primary

Measure	Time frame
Change in a composite score of cognitive function from baseline to a 24-month follow-up.	—

Secondary

Measure	Time frame
1) Changes in brain images assessed using MRI from baseline to a 24-month follow-up. 2) Changes in scores of each cognitive test from baseline to a 24-month follow-up. 3) Changes in ADL scores from baseline to a 24-month follow-up. 4) Changes in the status of frailty from baseline to a 24-month follow-up. 5) Changes in each result of a comprehensive geriatric assessment from baseline to a24-month follow-up. 6) Incident dementia.	—

Measure

Time frame

1) Changes in brain images assessed using MRI from baseline to a 24-month follow-up. 2) Changes in scores of each cognitive test from baseline to a 24-month follow-up. 3) Changes in ADL scores from baseline to a 24-month follow-up. 4) Changes in the status of frailty from baseline to a 24-month follow-up. 5) Changes in each result of a comprehensive geriatric assessment from baseline to a24-month follow-up. 6) Incident dementia.

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Countries

Japan

Contacts

Public ContactTaiki Sugimoto

National Center for Geriatrics and Gerontology Center for Comprehensive Care and Research on Memory Disorders

taiki-s@ncgg.go.jp0562462311

Outcome results