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

• Sponsor: Gdansk University of Physical Education and Sport (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT03903601
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Anticipated Duration (Months): 4
• Patients Per Site Per Month: 74.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vascular Diseases; Leukoaraiosis; Ischemia, Cerebral	Diagnostic Test: Magnetic Resonance Imaging (MRI); Diagnostic Test: Blood samples collection; Diagnostic Test: Neuropsychological tests

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 Design

• Study Type: Observational
• Anticipated Enrollment: 300 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Concentration of Trimethylamine Oxide (TMAO) in Blood Plasma as a Risk Factor for Vascular Cerebral Damage
• Anticipated Study Start Date: Dec 30, 2021
• Anticipated Primary Completion Date: Apr 30, 2022
• Anticipated Study Completion Date: May 1, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

1. Brain-derived neurotrophic factor (BDNF) [up to 4 weeks after brain MRI]

   BDNF concentration determined in serum by ELISA method, marked in pg/mg.

2. Mini Mental State Examination (MMSE) [up to 4 weeks after brain MRI]

   MMSE is a screening tool for cognitive functions impairment.

3. Trail Making Test (TMT) [up to 4 weeks after brain MRI]

   TMT test to determine the executive functions.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Physical Education and Sport	Gdansk	Pomorskie	Poland	80-336

Sponsors and Collaborators

• Gdansk University of Physical Education and Sport

Investigators

• Principal Investigator: Robert A Olek, PhD, Gdansk University of Physical Education and Sport

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Robert Olek, Associate Professor, Gdansk University of Physical Education and Sport
• ClinicalTrials.gov Identifier: NCT03903601
• Other Study ID Numbers: DSRiK/10/2019
• First Posted: Apr 4, 2019
• Last Update Posted: Jul 20, 2021
• Last Verified: Feb 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Robert Olek, Associate Professor, Gdansk University of Physical Education and Sport: trimethylamine-N-oxide; magnetic resonance imaging; cognitive functions
• Additional relevant MeSH terms: Brain Ischemia; Brain Injuries; Vascular Diseases; Ischemia; Leukoaraiosis

Study Results

No Results Posted as of Jul 20, 2021