Functional MRI Biomarkers of Cognitive Decrements in Diabetes
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|ClinicalTrials.gov Identifier: NCT01705210|
Recruitment Status : Completed
First Posted : October 12, 2012
Last Update Posted : April 10, 2015
|Condition or disease|
|Diabetes Mellitus, Type 2 Metabolic Syndrome X Mild Cognitive Impairment|
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.
|Study Type :||Observational|
|Actual Enrollment :||106 participants|
|Official Title:||Functional MRI Biomarkers of Cognitive Decrements in Diabetes|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
|Diabetes mellitus type 2 (DM2)|
|metabolic syndrome (MetS)|
- Functional and structural connectivity relationships of multiple brain regions and biomarkers of brain alterations [ Time Frame: subjects will be assessed once (on 1 day) ]Differences in macro-structural, micro-structural, and metabolic concentrations between patients and healthy controls will be evaluated. These MRI measures include volumetric characteristics (e.g. hyper-intensities, white matter lesions, atrophy), quantitative measures (e.g. T2 relaxation times, mean diffusivity, fractional anisotropy), functional characteristics (e.g. activated regions, cerebral blood flow), metabolic characteristics (e.g. concentration of metabolites), network properties (e.g. functional and structural connectivity, graph-theoretical measures).
- Anthropometrics [ Time Frame: subjects will be assessed once (on 1 day) ]Simple anthropometric measurements will include: Body mass index will be calculated as the weight (kg) divided by the square of the height (m). Waist circumference (WC) will be taken as the minimum circumference between the umbilicus and xiphoid process and measured to the nearest 0.5 cm.
- Mental health [ Time Frame: subjects will be assessed once (on 1 day) ]For assessment of mental health, specifically depression, the Cambridge Mental Disorders of the Elderly Examination will be used.
- Lifestyle [ Time Frame: subjects will be assessed once (on 1 day) ]Lifestyle specifics, including alcohol consumption, smoking behavior and mobility will be obtained through a questionnaire.
- Cardiovascular risk factors [ Time Frame: subjects will be assessed once (on 1 day) ]
Blood samples will be assessed for:
Fasting circulating levels of glucose, albumin, creatinin, total cholesterol, LDL- and HDL-cholesterol, triglycerides, HbA1c and uric acid.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01705210
|Maastricht University Medical Center|
|Maastricht, Netherlands, 6202 AZ|
|Principal Investigator:||Jacobus FA Jansen, PhD||Maastricht University Medical Center|