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BMC Endocrine Disorders
Published in: BMC Endocrine Disorders 1/2017

Open Access 01-12-2017 | Study protocol

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

Authors: Sheila K. Patel, Carolina Restrepo, Emilio Werden, Leonid Churilov, Elif I. Ekinci, Piyush M. Srivastava, Jay Ramchand, Bryan Wai, Brian Chambers, Christopher J. O’Callaghan, David Darby, Vladimir Hachinski, Toby Cumming, Geoff Donnan, Louise M. Burrell, Amy Brodtmann

Published in: BMC Endocrine Disorders | Issue 1/2017

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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 (ACTRN12616000546​459), date registered, 28/04/2016
Appendix
Available only for authorised users
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Metadata
Title
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
Authors
Sheila K. Patel
Carolina Restrepo
Emilio Werden
Leonid Churilov
Elif I. Ekinci
Piyush M. Srivastava
Jay Ramchand
Bryan Wai
Brian Chambers
Christopher J. O’Callaghan
David Darby
Vladimir Hachinski
Toby Cumming
Geoff Donnan
Louise M. Burrell
Amy Brodtmann
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Endocrine Disorders / Issue 1/2017
Electronic ISSN: 1472-6823
DOI
https://doi.org/10.1186/s12902-017-0173-7

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