Abstract
BackgroundCognitive impairment is common in type 2 diabetes mellitus, and there is a strong association between type 2 diabetes and Alzheimer’s disease. However, we do not know which type 2 diabetes patients will dement or which biomarkers predict cognitive decline. Left ventricular hypertrophy (LVH) is potentially such a marker. LVH is highly prevalent in type 2 diabetes and is a strong, independent predictor of cardiovascular events. To date, no studies have investigated the association between LVH and cognitive decline in type 2 diabetes. The Diabetes and Dementia (D2) study is designed to establish whether patients with type 2 diabetes and LVH have increased rates of brain atrophy and cognitive decline.MethodsThe D2 study is a single centre, observational, longitudinal case control study that will follow 168 adult patients aged >50 years with type 2 diabetes: 50% with LVH (case) and 50% without LVH (control). It will assess change in cardiovascular risk, brain imaging and neuropsychological testing between two time-points, baseline (0 months) and 24 months. The primary outcome is brain volume change at 24 months. The co-primary outcome is the presence of cognitive decline at 24 months. The secondary outcome is change in left ventricular mass associated with brain atrophy and cognitive decline at 24 months.DiscussionThe D2 study will test the hypothesis that patients with type 2 diabetes and LVH will exhibit greater brain atrophy than those without LVH. An understanding of whether LVH contributes to cognitive decline, and in which patients, will allow us to identify patients at particular risk.Trial registrationAustralian New Zealand Clinical Trials Registry (ACTRN12616000546459), date registered, 28/04/2016
Highlights
Cognitive impairment is common in type 2 diabetes mellitus, and there is a strong association between type 2 diabetes and Alzheimer’s disease
Type 2 diabetes mellitus is associated with an increased risk of dementia [1, 2] and a two-fold increase in the risk of Alzheimer’s disease [3]
A strong association between midlife vascular risk factors and structural brain aging has been demonstrated [8], longitudinal brain volume changes have not been thoroughly examined in patients with type 2 diabetes
Summary
Cognitive impairment is common in type 2 diabetes mellitus, and there is a strong association between type 2 diabetes and Alzheimer’s disease. No studies have investigated the association between LVH and cognitive decline in type 2 diabetes. The Diabetes and Dementia (D2) study is designed to establish whether patients with type 2 diabetes and LVH have increased rates of brain atrophy and cognitive decline. Type 2 diabetes mellitus is associated with an increased risk of dementia [1, 2] and a two-fold increase in the risk of Alzheimer’s disease [3]. A diagnosis of diabetes in midlife increases the risk of both vascular cognitive impairment and Alzheimer’s disease [5]. A strong association between midlife vascular risk factors and structural brain aging has been demonstrated [8], longitudinal brain volume changes have not been thoroughly examined in patients with type 2 diabetes. The PROSPER study findings suggested that elderly non-demented patients with type 2 diabetes had accelerated progression of brain atrophy compared to non-diabetic individuals and provided evidence for the hypothesis that diabetes exerts deleterious effects on neuronal integrity [9]
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