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How does heart disease affect cognition and brain structural integrity in diabetes?

How does cardiovascular disease affect cognition in diabetes? Cardiovascular risk and the diabetic brain

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12616000546459
Acronym
D2 study
Enrollment
150
Registered
2016-04-28
Start date
2016-05-20
Completion date
2020-03-27
Last updated
2026-06-15

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

Conditions

None listed

Brief summary

Type 2 diabetes mellitus and dementia are two of the commonest and most disabling conditions worldwide, responsible for an enormous and growing burden of disease. There is increasing awareness that the two conditions are linked, with cognitive impairment (worsening memory, thinking, perception) common in patients type 2 diabetes, and a strong association between type 2 diabetes and Alzheimer’s disease, the most common form of dementia. Better markers are needed for the prediction of cognitive decline in people with diabetes. Left ventricular hypertrophy (LVH) is an enlargement and thickening (hypertrophy) of the walls of the hearts main pumping chamber, which is common in type 2 diabetes. To date there have been no studies on the association between LVH and cognitive decline in type 2 diabetes. The purpose of this study is to establish whether people with type 2 diabetes and LVH have increased rates of brain volume changes and cognitive impairment. An understanding of whether LVH is contributing to cognitive decline will allow us to identify patients at particular risk.

Interventions

This is a single center observational longitudinal case control study that will follow 168 adult patients aged >50 years with type 2 diabetes mellitus, 50% with left ventricular hypertophy (LVH, case) and 50% without LVH (control). Baseline testing will include: demographic and medical history questionnaire, measurement of height, weight, waist and hip, echocardiogram, ECG, carotid ultrasound, 24 hour ambulatory blood pressure monitor, cognitive assessment, magnetic resonance imaging (MRI), phy

This is a single center observational longitudinal case control study that will follow 168 adult patients aged >50 years with type 2 diabetes mellitus, 50% with left ventricular hypertophy (LVH, case) and 50% without LVH (control). Baseline testing will include: demographic and medical history questionnaire, measurement of height, weight, waist and hip, echocardiogram, ECG, carotid ultrasound, 24 hour ambulatory blood pressure monitor, cognitive assessment, magnetic resonance imaging (MRI), physical activity monitor and a blood sample (to determine HbA1c level, APOE genetic risk assessment). Participants will return for tests at the 2 year time-point.

Sponsors

The Florey Institute of Neuroscience and Mental Health
Lead SponsorOther

Eligibility

Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Diagnosed with type 2 diabetes 2. Aged over 50 years 3. Able to attend 2 study sessions 2 years apart 4. Have no prior neurological or psychiatric disease, including stroke or dementia 5. Can give informed consent and participate in cognitive testing and MRI scans.

Exclusion criteria

1. Known prior stroke or dementia 2. Significant medical co-morbidities making survival for 24 months unlikely 3. Normal exclusion criteria for MRI, e.g. pacemaker, implanted metal, severe claustrophobia 4. Severe diabetic nephropathy, eGFR<30

Outcome results

None listed

Source: ANZCTR · Data processed: Jun 21, 2026