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

G

Gdansk University of Physical Education and Sport

Status

Unknown

Conditions

Ischemia, Cerebral
Leukoaraiosis
Vascular Diseases

Treatments

Diagnostic Test: Blood samples collection
Diagnostic Test: Neuropsychological tests
Diagnostic Test: Magnetic Resonance Imaging (MRI)

Study type

Observational

Funder types

Other

Identifiers

NCT03903601
DSRiK/10/2019

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

300 participants in 2 patient groups

Ischemic changes
Description:
Patients with ischemic changes in the brain diagnosed by MRI
Treatment:
Diagnostic Test: Magnetic Resonance Imaging (MRI)
Diagnostic Test: Neuropsychological tests
Diagnostic Test: Blood samples collection
No ischemic changes
Description:
Patients without ischemic changes in the brain diagnosed by MRI
Treatment:
Diagnostic Test: Magnetic Resonance Imaging (MRI)
Diagnostic Test: Neuropsychological tests
Diagnostic Test: Blood samples collection

Trial contacts and locations

0

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Central trial contact

Robert A Olek, PhD

Data sourced from clinicaltrials.gov

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