Completed

Cerebral Biomarkers of Cognitive Decrements in Diabetes and Metabolic Syndrome using Functional MRI

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Study Aim

This observational study aims to identify differences in brain structure and function between patients with diabetes and metabolic syndrome and healthy individuals, using functional MRI to assess various brain characteristics such as volume, connectivity, and metabolite concentration.

What is being collected

Data Collection

Collected at a single point in time - Cross-sectional
Who is being recruted

Mental Disorders+10

+ Cognition Disorders

+ Diabetes Mellitus

From 40 to 75 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: May 2012
See protocol details

Summary

Principal SponsorMaastricht University Medical Center
Last updated: April 10, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01705210
Principal SponsorMaastricht University Medical Center
Last updated: April 10, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

106 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 40 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersCognition DisordersDiabetes MellitusEndocrine System DiseasesHyperinsulinismInsulin ResistanceMetabolic DiseasesNutritional and Metabolic DiseasesNeurocognitive DisordersGlucose Metabolism DisordersDiabetes Mellitus, Type 2Metabolic SyndromeCognitive Dysfunction

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]: 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. 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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Maastricht University Medical Center

Maastricht, NetherlandsOpen Maastricht University Medical Center in Google Maps
CompletedOne Study Center