Functional MRI Biomarkers of Cognitive Decrements in Diabetes
Functional MRI Biomarkers of Cognitive Decrements in Diabetes
Sponsors
Source
Maastricht University Medical Center
Oversight Info
Has Dmc
No
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.
Overall Status
Completed
Start Date
2012-05-01
Completion Date
2015-04-01
Primary Completion Date
2015-04-01
Study Type
Observational
Primary Outcome
Measure |
Time Frame |
|
Functional and structural connectivity relationships of multiple brain regions and biomarkers of brain alterations |
subjects will be assessed once (on 1 day) |
Secondary Outcome
Measure |
Time Frame |
|
Anthropometrics |
subjects will be assessed once (on 1 day) |
|
Mental health |
subjects will be assessed once (on 1 day) |
|
Lifestyle |
subjects will be assessed once (on 1 day) |
|
Cardiovascular risk factors |
subjects will be assessed once (on 1 day) |
Number Of Groups
3
Enrollment
106
Conditions
Eligibility
Study Pop
Matched subjects aged 40-75 years with Diabetes mellitus type 2, metabolic syndrome, and
healthy controls
Sampling Method
Probability Sample
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
Gender
All
Minimum Age
40 Years
Maximum Age
75 Years
Healthy Volunteers
Accepts Healthy Volunteers
Overall Official
Last Name |
Role |
Affiliation |
|
Jacobus FA Jansen, PhD |
Principal Investigator |
Maastricht University Medical Center |
Location
Facility |
|
Maastricht University Medical Center Maastricht 6202 AZ Netherlands |
Location Countries
Country
Netherlands
Verification Date
2015-04-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Has Expanded Access
No
Condition Browse
Secondary Id
916.11.059
Arm Group
Arm Group Label
Diabetes mellitus type 2 (DM2)
Arm Group Label
metabolic syndrome (MetS)
Arm Group Label
healthy controls
Results Reference
Citation
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.
PMID
25690006
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Observational Model
Cohort
Time Perspective
Cross-Sectional
Study First Submitted
June 6, 2012
Study First Submitted Qc
October 11, 2012
Study First Posted
October 12, 2012
Last Update Submitted
April 9, 2015
Last Update Submitted Qc
April 9, 2015
Last Update Posted
April 10, 2015
ClinicalTrials.gov processed this data on December 09, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.