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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
Sponsor:
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
Netherlands Organisation for Scientific Research
Information provided by (Responsible Party):
Maastricht University Medical Center

Tracking Information
First Submitted Date June 6, 2012
First Posted Date October 12, 2012
Last Update Posted Date April 10, 2015
Study Start Date May 2012
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 11, 2012)
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).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 11, 2012)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Functional MRI Biomarkers of Cognitive Decrements in Diabetes
Official Title Functional MRI Biomarkers of Cognitive Decrements in Diabetes
Brief 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Matched subjects aged 40-75 years with Diabetes mellitus type 2, metabolic syndrome, and healthy controls
Condition
  • Diabetes Mellitus, Type 2
  • Metabolic Syndrome X
  • Mild Cognitive Impairment
Intervention Not Provided
Study Groups/Cohorts
  • Diabetes mellitus type 2 (DM2)
  • metabolic syndrome (MetS)
  • healthy controls
Publications * van Bussel FC, Backes WH, Hofman PA, van Oostenbrugge RJ, Kessels AG, van Boxtel MP, Schram MT, Stehouwer CD, Wildberger JE, Jansen JF. On the interplay of microvasculature, parenchyma, and memory in type 2 diabetes. Diabetes Care. 2015 May;38(5):876-82. doi: 10.2337/dc14-2043. Epub 2015 Feb 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 9, 2015)
106
Original Estimated Enrollment
 (submitted: October 11, 2012)
132
Actual Study Completion Date April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion criteria:

  • Subjects aged 40-75 years
  • Subjects enrolled in the existing 'Maastricht Study' (M-Study)
  • Subjects gave written consent to be approached for additional research
  • Subjects belongs to the 20% of the worst and 20% of the best performing (as based on neuropsychological cognitive testing (Stroop color-word test, 15 word learning test, and Delayed recall and recognition 15 word learning test)

Individuals Diabetes type 2:

- Fasting blood glucose ≥ 7.0 mmol/l, after an oral glucose tolerance test (OGTT)blood glucose ≥ 11.1 mmol/l or used oral glucose-lowering medication or insulin

Metabolic syndrome:

  • Participants should meet three out of 5 of the following criteria [8]:

    1. Waist circumference > 88 cm (women), > 102 cm (men)
    2. Triglycerides ≥ 1.7 mmol/l
    3. HDL cholesterol < 1.3 mmol/l (women), < 1.0 mmol/l (men)
    4. Blood pressure ≥ 130/85 mmHg (or medication)
    5. Fasting blood glucose ≥ 6.1 mmol/l, after an OGTT blood glucose ≥ 7.8 mmol/l

      Control participants:

  • Those who fulfilled no more than 1 criterium of the metabolic syndrome, no DM2.

Exclusion criteria:

  • Contra-indications for MRI examination (e.g. pacemaker; neurostimulator; medication pump; cochlear or hearing implant; tattoos or other items that cannot be removed and include metal parts (for instance from operations in the past); metal splinter in the eye; pregnancy and claustrophobia; brain vessel clamps; denture, which contains magnets).
  • Psychiatric co-morbidity and inability to perform the functional MRI tests.
  • Incomplete cognitive assessment data
  • Diabetes mellitus type 1 (DM1)
  • Subjects who are not belonging to the 20% of the worst and 20% of the best performing individuals (as based on neuropsychological cognitive testing (Stroop color-word test, 15 word learning test, and Delayed recall and recognition 15 word learning test).
  • Last visit of the subjects to the M-Study should be less than one year
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT01705210
Other Study ID Numbers NL34329.068.10 / METC 10-2-023
916.11.059 ( Other Grant/Funding Number: NWO/ZonMW VENI )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Maastricht University Medical Center
Original Responsible Party Same as current
Current Study Sponsor Maastricht University Medical Center
Original Study Sponsor Same as current
Collaborators
  • ZonMw: The Netherlands Organisation for Health Research and Development
  • Netherlands Organisation for Scientific Research
Investigators
Principal Investigator: Jacobus FA Jansen, PhD Maastricht University Medical Center
PRS Account Maastricht University Medical Center
Verification Date April 2015