Concentration of Trimethylamine Oxide (TMAO) in Blood Plasma as a Risk Factor for Vascular Cerebral Damage
- Conditions
- LeukoaraiosisIschemia, CerebralVascular Diseases
- Interventions
- Diagnostic Test: Magnetic Resonance Imaging (MRI)Diagnostic Test: Blood samples collectionDiagnostic Test: Neuropsychological tests
- Registration Number
- NCT03903601
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
- the ischemic changes in the brain (diagnosed by neurologist by MRI scans)
- no ischemic changes in the brain (diagnosed by neurologist by MRI scans)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ischemic changes Magnetic Resonance Imaging (MRI) Patients with ischemic changes in the brain diagnosed by MRI Ischemic changes Blood samples collection Patients with ischemic changes in the brain diagnosed by MRI Ischemic changes Neuropsychological tests Patients with ischemic changes in the brain diagnosed by MRI No ischemic changes Magnetic Resonance Imaging (MRI) Patients without ischemic changes in the brain diagnosed by MRI No ischemic changes Blood samples collection Patients without ischemic changes in the brain diagnosed by MRI No ischemic changes Neuropsychological tests Patients without ischemic changes in the brain diagnosed by MRI
- Primary Outcome Measures
Name Time Method Brain Magnetic Resonance Imaging (MRI) 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.
Trimethylamine-N-oxide (TMAO) blood concentration 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
Name Time Method Brain-derived neurotrophic factor (BDNF) up to 4 weeks after brain MRI BDNF concentration determined in serum by ELISA method, marked in pg/mg.
Mini Mental State Examination (MMSE) up to 4 weeks after brain MRI MMSE is a screening tool for cognitive functions impairment.
Trail Making Test (TMT) up to 4 weeks after brain MRI TMT test to determine the executive functions.
Trial Locations
- Locations (1)
University of Physical Education and Sport
🇵🇱Gdansk, Pomorskie, Poland