Clinical Trials Directory

Trials / Completed

CompletedNCT01705210

Functional MRI Biomarkers of Cognitive Decrements in Diabetes

Status
Completed
Phase
Study type
Observational
Enrollment
106 (actual)
Sponsor
Maastricht University Medical Center · Academic / Other
Sex
All
Age
40 Years – 75 Years
Healthy volunteers
Accepted

Summary

The exact neuronal mechanism underlying the cognitive decline associated with diabetes mellitus type 2 (DM2) still remains to be elucidated. Multi-parametric functional MRI can potentially provide functional, micro-structural, micro-vascular, and metabolic information on the affected brain at an earlier stage than does conventional structural MRI. The overall aim of the current proposal is to obtain a better understanding in the neuronal mechanisms that underlie cognitive decline in DM2 and the putative prediabetic condition the metabolic syndrome (MetS).

Detailed description

Diabetes mellitus type 2 (DM2) is a common chronic metabolic disorder that affects 4.1% of the Dutch population. In addition to vascular disease, DM2 is associated with structural brain changes visible on MRI, accelerated cognitive decline, and dementia in older individuals. The exact pathophysiological mechanisms underlying cognitive decrements in DM2 still remain to be elucidated. The 'metabolic syndrome' (MetS), defined as a cluster of cardiovascular risk factors (including obesity, hypertension, and dyslipidemia) is often considered a prediabetic condition. Individuals with MetS display similar cognitive decrements as do DM2 patients, but do not share the severity of brain injury. It has been indicated that in prediabetic MetS, cognitive problems precede structural brain changes, and that MetS and DM2 affect the brain through a shared mechanism in which vascular co-morbidity is essential. The primary objectives are defined according to a hierarchical design: i) to tailor and apply multi-parametric, functional MRI techniques to identify cerebral abnormalities (cerebral biomarkers) in DM2 and MetS; ii) to investigate which cerebral biomarkers are shared and differ between DM2 and MetS; iii) to assess whether these cerebral biomarkers are associated with cognitive decrements.

Conditions

Timeline

Start date
2012-05-01
Primary completion
2015-04-01
Completion
2015-04-01
First posted
2012-10-12
Last updated
2015-04-10

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT01705210. Inclusion in this directory is not an endorsement.