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

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