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

July 19, 2021 updated by: Robert Olek, Gdansk University of Physical Education and Sport

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-336
        • University of Physical Education and Sport

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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)

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
before qualifying for the study, during the recruitment period
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.
up to 4 weeks after brain MRI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 4 weeks after brain MRI
Mini Mental State Examination (MMSE)
Time Frame: up to 4 weeks after brain MRI
MMSE is a screening tool for cognitive functions impairment.
up to 4 weeks after brain MRI
Trail Making Test (TMT)
Time Frame: up to 4 weeks after brain MRI
TMT test to determine the executive functions.
up to 4 weeks after brain MRI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gdansk University of Physical Education and Sport

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

December 30, 2021

Primary Completion (ANTICIPATED)

April 30, 2022

Study Completion (ANTICIPATED)

May 1, 2022

Study Registration Dates

First Submitted

April 1, 2019

First Submitted That Met QC Criteria

April 2, 2019

First Posted (ACTUAL)

April 4, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 20, 2021

Last Update Submitted That Met QC Criteria

July 19, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DSRiK/10/2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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