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Concentration of Trimethylamine Oxide (TMAO) in Blood Plasma as a Risk Factor for Vascular Cerebral Damage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03903601
Recruitment Status : Not yet recruiting
First Posted : April 4, 2019
Last Update Posted : February 6, 2020
Sponsor:
Information provided by (Responsible Party):
Robert Olek, Gdansk University of Physical Education and Sport

Brief Summary:

The primary aim of the current research project is to answer the question, whether plasma trimethylamine N-oxide (TMAO) level may be used as a marker of ischemic changes in the brain. TMAO is associated with endothelial dysfunction, inflammation and oxidative stress.

The hypothesis is that circulating TMAO level may predict leukoaraiosis (LA) and/or stroke.

Secondary, the investigators would like to examine whether plasma TMAO concentration is related to cognitive impairment and determine whether choline consumption is associated with an incidence of LA severity and dementia.


Condition or disease Intervention/treatment
Vascular Diseases Leukoaraiosis Ischemia, Cerebral Diagnostic Test: Magnetic Resonance Imaging (MRI) Diagnostic Test: Blood samples collection Diagnostic Test: Neuropsychological tests

Detailed Description:

In the study, subjects will be recruited in the hospital among the patients with brain MRI performed within past 4 weeks. All MRI scans will be reviewed by the neurologist to evaluate ischemic changes. Upon detection of LA, patients (n=150) will be informed about the study aims. In the same time, aged- and sex-matched control group (n=150) with no detected ischemic changes will be recruited.

In each group, the blood samples will be collected, to determine the concentration of plasma TMAO, oxidative stress markers, as well as serum endothelial dysfunction markers and biochemical parameters. To determine the cognitive performance psychological test will be carried out. The diet of all recruited participants, with special consideration on the choline-rich products and supplements, will be analyzed.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Concentration of Trimethylamine Oxide (TMAO) in Blood Plasma as a Risk Factor for Vascular Cerebral Damage
Estimated Study Start Date : May 30, 2020
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Group/Cohort Intervention/treatment
Ischemic changes
Patients with ischemic changes in the brain diagnosed by MRI
Diagnostic Test: Magnetic Resonance Imaging (MRI)
Magnetic Resonance Imaging (MRI) to diagnose ischemic changes in the brain.

Diagnostic Test: Blood samples collection
Trimethylamine N-oxide (TMAO) concentration, oxidative stress markers and endothelial dysfunction markers will be determined in blood samples.

Diagnostic Test: Neuropsychological tests
Cognitive functions assessment

No ischemic changes
Patients without ischemic changes in the brain diagnosed by MRI
Diagnostic Test: Magnetic Resonance Imaging (MRI)
Magnetic Resonance Imaging (MRI) to diagnose ischemic changes in the brain.

Diagnostic Test: Blood samples collection
Trimethylamine N-oxide (TMAO) concentration, oxidative stress markers and endothelial dysfunction markers will be determined in blood samples.

Diagnostic Test: Neuropsychological tests
Cognitive functions assessment




Primary Outcome Measures :
  1. Brain Magnetic Resonance Imaging (MRI) [ Time Frame: before qualifying for the study, during the recruitment period ]
    Leukoaraiosis severity will be evaluated in MRI scans according to the Fazekas' scale. Will be grading scale for periventricular hyperintensities (PVH) and scale of deep white matter hyperintensities.

  2. Trimethylamine-N-oxide (TMAO) blood concentration [ Time Frame: up to 4 weeks after brain MRI ]
    TMAO concentration determined by the ultra-performance liquid-chromatography tandem mass spectrometry (UPLC-MS/MS), marked in µmol/l.


Secondary Outcome Measures :
  1. Brain-derived neurotrophic factor (BDNF) [ Time Frame: up to 4 weeks after brain MRI ]
    BDNF concentration determined in serum by ELISA method, marked in pg/mg.

  2. Mini Mental State Examination (MMSE) [ Time Frame: up to 4 weeks after brain MRI ]
    MMSE is a screening tool for cognitive functions impairment.

  3. Trail Making Test (TMT) [ Time Frame: up to 4 weeks after brain MRI ]
    TMT test to determine the executive functions.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients from 7th Navy Hospital in Gdansk, which had a brain MRI performed within the past 4 weeks.
Criteria

Inclusion Criteria:

  • the ischemic changes in the brain (diagnosed by neurologist by MRI scans)

Exclusion Criteria:

  • no ischemic changes in the brain (diagnosed by neurologist by MRI scans)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03903601


Contacts
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Contact: Robert A Olek, PhD 58 5547392 ext +48 robol@awf.gda.pl

Locations
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Poland
University of Physical Education and Sport
Gdansk, Pomorskie, Poland, 80-336
Sponsors and Collaborators
Gdansk University of Physical Education and Sport
Investigators
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Principal Investigator: Robert A Olek, PhD Gdansk University of Physical Education and Sport
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Responsible Party: Robert Olek, Associate Professor, Gdansk University of Physical Education and Sport
ClinicalTrials.gov Identifier: NCT03903601    
Other Study ID Numbers: DSRiK/10/2019
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Robert Olek, Gdansk University of Physical Education and Sport:
trimethylamine-N-oxide
magnetic resonance imaging
cognitive functions
Additional relevant MeSH terms:
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Brain Injuries
Brain Ischemia
Vascular Diseases
Ischemia
Leukoaraiosis
Pathologic Processes
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Cerebrovascular Disorders