An observational study in Diabetes Mellitus, Type 2, Metabolic Syndrome X and Mild Cognitive Impairment, sponsored by Maastricht University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 40 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-10.
Sponsored by Maastricht University Medical Center · Observational
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).
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 106 is below the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.
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Matched subjects aged 40-75 years with Diabetes mellitus type 2, metabolic syndrome, and healthy controls
Individuals Diabetes type 2:
Metabolic syndrome:
Participants should meet three out of 5 of the following criteria [8]:
Fasting blood glucose ≥ 6.1 mmol/l, after an OGTT blood glucose ≥ 7.8 mmol/l
Control participants:
Exclusion criteria:
Functional and structural connectivity relationships of multiple brain regions and biomarkers of brain alterations
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).
Time frame: subjects will be assessed once (on 1 day)
Anthropometrics
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.
Time frame: subjects will be assessed once (on 1 day)
Mental health
For assessment of mental health, specifically depression, the Cambridge Mental Disorders of the Elderly Examination will be used.
Time frame: subjects will be assessed once (on 1 day)
Lifestyle
Lifestyle specifics, including alcohol consumption, smoking behavior and mobility will be obtained through a questionnaire.
Time frame: subjects will be assessed once (on 1 day)
Cardiovascular risk factors
Blood samples will be assessed for: Fasting circulating levels of glucose, albumin, creatinin, total cholesterol, LDL- and HDL-cholesterol, triglycerides, HbA1c and uric acid.
Time frame: subjects will be assessed once (on 1 day)
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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Maastricht University Medical Center