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

Vascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03903601
• Other study ID #: DSRiK/10/2019
• Status: Not yet recruiting
• Start date: December 30, 2021
• Est. completion date: May 2022

Study information

• Verified date: February 2021
• Source: Gdansk University of Physical Education and Sport
• Contact: Robert A Olek, PhD
• Phone: 58 5547392
• Email: robol[@]awf.gda.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: May 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Brain Injuries
• Brain Ischemia
• Ischemia
• Ischemia, Cerebral
• Leukoaraiosis
• Vascular Diseases

Intervention

Diagnostic Test:
• Magnetic Resonance Imaging (MRI)
Magnetic Resonance Imaging (MRI) to diagnose ischemic changes in the brain.
• Blood samples collection
Trimethylamine N-oxide (TMAO) concentration, oxidative stress markers and endothelial dysfunction markers will be determined in blood samples.
• Neuropsychological tests
Cognitive functions assessment

Locations

Country	Name	City	State
Poland	University of Physical Education and Sport	Gdansk	Pomorskie

Sponsors (1)

Lead Sponsor	Collaborator
Gdansk University of Physical Education and Sport

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain Magnetic Resonance Imaging (MRI)	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
Primary	Trimethylamine-N-oxide (TMAO) blood concentration	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	Brain-derived neurotrophic factor (BDNF)	BDNF concentration determined in serum by ELISA method, marked in pg/mg.	up to 4 weeks after brain MRI
Secondary	Mini Mental State Examination (MMSE)	MMSE is a screening tool for cognitive functions impairment.	up to 4 weeks after brain MRI
Secondary	Trail Making Test (TMT)	TMT test to determine the executive functions.	up to 4 weeks after brain MRI