Functional MRI Biomarkers of Cognitive Decrements in Diabetes

NCT01705210 | Completed

• 2 other identifiers: NL34329.068.10 / METC 10-2-023916.11.059
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetes Mellitus, Type 2; Metabolic Syndrome X; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (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).

  subjects will be assessed once (on 1 day)

Secondary Outcomes (4)

• 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)

Study Arms (3)

Diabetes mellitus type 2 (DM2)

metabolic syndrome (MetS)

healthy controls

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• Netherlands Organisation for Scientific Research: collaborator

Study Sites (1)

Maastricht University Medical Center

Maastricht, 6202 AZ, Netherlands

Location

Related Publications (1)

• 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 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Metabolic Syndrome; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jacobus FA Jansen, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2012
• First Posted: October 12, 2012
• Study Start: May 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: April 10, 2015

Record last verified: 2015-04

Locations

NL (1)