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Diabetes Mellitus, Type 2NCT01705210

Functional MRI Biomarkers of Cognitive Decrements in Diabetes

An observational study of Diabetes Mellitus, Type 2 and Metabolic Syndrome X, run by Maastricht University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 75 yearsHealthy volunteers can take part
How many people
106 participants
Where
1 siteNetherlands
Study dates
May 2012to Apr 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Matched subjects aged 40-75 years with Diabetes mellitus type 2, metabolic syndrome, and healthy controls

Who may be able to join

  • 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
Show all 15Show fewer
  • Metabolic syndrome:
  • Participants should meet three out of 5 of the following criteria [8]:
  • Waist circumference > 88 cm (women), > 102 cm (men)
  • Triglycerides ≥ 1.7 mmol/l
  • HDL cholesterol < 1.3 mmol/l (women), < 1.0 mmol/l (men)
  • Blood pressure ≥ 130/85 mmHg (or medication)
  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Maastricht University Medical Center

    Maastricht, 6202 AZ

Other trials in Netherlands

About this study

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).

Read the 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.

Medical subject headings
Diabetes Mellitus, Type 2, Metabolic Syndrome, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01705210
Study groupRoleWhat they receive
Diabetes mellitus type 2 (DM2)Not described
metabolic syndrome (MetS)Not described
healthy controlsNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: subjects will be assessed once (on 1 day)

Secondary outcomes (4)

  1. 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.

    Measured: subjects will be assessed once (on 1 day)

  2. Mental health

    For assessment of mental health, specifically depression, the Cambridge Mental Disorders of the Elderly Examination will be used.

    Measured: subjects will be assessed once (on 1 day)

  3. Lifestyle

    Lifestyle specifics, including alcohol consumption, smoking behavior and mobility will be obtained through a questionnaire.

    Measured: subjects will be assessed once (on 1 day)

  4. 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.

    Measured: subjects will be assessed once (on 1 day)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionApr 2015
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01705210
Sponsor's protocol ID
NL34329.068.10 / METC 10-2-023
Other IDs
916.11.059
Status last verified
Apr 2015
First submitted
6 Jun 2012
Last updated
10 Apr 2015
Results posted
No
Data monitoring committee
No

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.

    PubMed 25690006

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 2 and Metabolic Syndrome X, run by Maastricht University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional and structural connectivity relationships of multiple brain regions and biomarkers of brain alterations (time frame: subjects will be assessed once (on 1 day)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01705210, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2015.

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