Clinical Trial Details

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

Print record Print record
Trial Information

Broad Health Condition Neurological
Metabolic and Endocrine
Cardiovascular

Specific Health ConditionDementias
Diabetes
Other cardiovascular diseases

Trial Focus

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Hospital
Austin Health - Austin Hospital - Heidelberg


Postcode
3084 - Heidelberg

Anticipated date of first participant enrolment2/05/2016

Anticipated date of last participant enrolment2/05/2016

Has the study received ethics approval?Further information iconApproved

Trial 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.
Eligibility

Key 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.

Minimum age50 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key 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
Contact details and further information

Sponsor Primary Sponsor Type: Other
Primary Sponsor Name: The Florey Institute of Neuroscience and Mental Health
Primary Sponsor Address: 30 Royal Parade (corner Genetics Lane) Parkville Victoria 3052
Primary Sponsor Country: Australia

Trial IDACTRN12616000546459

UTNU1111-1181-6659

Contact person for information and recruitmentDr
Sheila Patel
The Florey Institute of Neuroscience and Mental Health Melbourne Brain Centre 245 Burgundy Street Heidelberg VIC 3084
+61 3 9035 7021
+61 3 9035 7301
Further information iconskpatel@unimelb.edu.au
Australia