Cognitive Decline, Diabetes Mellitus, Type 2, Heart Failure
Conditions
Keywords
Dementia, Stroke Prevention
Brief summary
Type 2 diabetes is a risk factor of heart failure and cognitive decline. Heart failure at its early stage is often silent. At present, primary prevention for heart failure is not available. Our aim is to identify diabetic patients at risk of heart failure in order to develop personalized preventive strategies. Type 2 diabetes is vascular and metabolic risk factor for cognitive decline though a direct lesional effect but also through an interaction with underlying neurodegenerative lesions. Our aim is to identify diabetic patients at risk of cognitive decline in order to develop personalized preventive strategies
Interventions
None listed
Sponsors
University Hospital, Lille
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults * Persons able to understand and object to the information provided. * Type 2 diabetic patient free of heart failure ≥stade B * Patient affiliated with a social security scheme. * Patient agreeing to sign the informed consent form
Exclusion criteria
* Patient with dementia * Patient with at least one of the criteria for heart failure ≥stade B
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Heart failure (≥ stade B). | at 48 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive decline (composite endpoint) | at 48 months | * a decrease in cognitive performance quantified at 1.5 standard deviation on at least 1 neuropsychological test within a cognitive domain (attention and speed of information processing, memory, executive functions) compared to the neuropsychological assessment performed at inclusion. * Appearance of dementia defined as a cognitive disorder highlighted in the neuropsychological evaluation carried out at the end of the study leading to a loss of functional autonomy in activities of daily living defined by the loss of at least 1 point on the activities of daily living ADL scale (DSM V). |
| Major cardio-neuro-vascular events | at 48 months | cardioneurovascular event (composite endpoint) defined by the occurrence of death from any cause, myocardial infarction, stroke (ischemic or hemorrhagic), acute limb ischemia or a doubling of creatinine. |
Countries
France
Contacts
Primary ContactCharlotte Cordonnier, MD,PhD
Outcome results
None listed