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Does left ventricular hypertrophy affect cognition and brain structural integrity in type 2 diabetes? Study design and rationale of the Diabetes and Dementia (D2) study.

Does left ventricular hypertrophy affect cognition and brain structural integrity in type 2 diabetes? Study design and rationale of the Diabetes and Dementia (D2) study.
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Patel SK, Restrepo C, Werden E, Churilov L, Ekinci EI, Srivastava PM, Ramchand J, Wai B, Chambers B, O'Callaghan CJ, Darby D, Hachinski V, Cumming T, Donnan G, Burrell LM, Brodtmann A,


Patel SK, Restrepo C, Werden E, Churilov L, Ekinci EI, Srivastava PM, Ramchand J, Wai B, Chambers B, O'Callaghan CJ, Darby D, Hachinski V, Cumming T, Donnan G, Burrell LM, Brodtmann A, (click to view)

Patel SK, Restrepo C, Werden E, Churilov L, Ekinci EI, Srivastava PM, Ramchand J, Wai B, Chambers B, O'Callaghan CJ, Darby D, Hachinski V, Cumming T, Donnan G, Burrell LM, Brodtmann A,

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BMC endocrine disorders 2017 04 0717(1) 24 doi 10.1186/s12902-017-0173-7
Abstract
BACKGROUND
Cognitive 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.

METHODS
The 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.

DISCUSSION
The 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 REGISTRATION
Australian New Zealand Clinical Trials Registry ( ACTRN12616000546459 ), date registered, 28/04/2016.

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