Vascular DiseasesNCT03903601
Concentration of Trimethylamine Oxide (TMAO) in Blood Plasma as a Risk Factor for Vascular Cerebral Damage
An observational study of Vascular Diseases and Leukoaraiosis, run by Gdansk University of Physical Education and Sport at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Vascular Diseases, Leukoaraiosis, Ischemia, Cerebral
- What is being tested?
- Magnetic Resonance Imaging (MRI), Blood samples collection and Neuropsychological tests
- How many people
- 300 participants
- Where
- 1 sitePoland
- Study dates
- 30 Dec 2021to May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients from 7th Navy Hospital in Gdansk, which had a brain MRI performed within the past 4 weeks.
Who may be able to join
- the ischemic changes in the brain (diagnosed by neurologist by MRI scans)
Who cannot join
- no ischemic changes in the brain (diagnosed by neurologist by MRI scans)
Trial locations and contacts
1 site in 1 country.
Poland1 site
University of Physical Education and Sport
Gdansk, Pomeranian Voivodeship, 80-336
About this study
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.
Read the 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.
- Conditions
- Vascular Diseases, Leukoaraiosis, Ischemia, Cerebral
- Being tested
- Magnetic Resonance Imaging (MRI), Blood samples collection, Neuropsychological tests
- Keywords
- trimethylamine-N-oxide, magnetic resonance imaging, cognitive functions
- Medical subject headings
- Vascular Diseases, Leukoaraiosis, Brain Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI)Diagnostic test
Magnetic Resonance Imaging (MRI) to diagnose ischemic changes in the brain.
Blood samples collectionDiagnostic test
Trimethylamine N-oxide (TMAO) concentration, oxidative stress markers and endothelial dysfunction markers will be determined in blood samples.
Neuropsychological testsDiagnostic test
Cognitive functions assessment
| Study group | Role | What they receive |
|---|---|---|
| Ischemic changes | Patients with ischemic changes in the brain diagnosed by MRI Receives: Diagnostic Test: Magnetic Resonance Imaging (MRI); Diagnostic Test: Blood samples collection; Diagnostic Test: Neuropsychological tests | |
| No ischemic changes | Patients without ischemic changes in the brain diagnosed by MRI Receives: Diagnostic Test: Magnetic Resonance Imaging (MRI); Diagnostic Test: Blood samples collection; Diagnostic Test: Neuropsychological tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: before qualifying for the study, during the recruitment period
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.
Measured: up to 4 weeks after brain MRI
Secondary outcomes (3)
Brain-derived neurotrophic factor (BDNF)
BDNF concentration determined in serum by ELISA method, marked in pg/mg.
Measured: up to 4 weeks after brain MRI
Mini Mental State Examination (MMSE)
MMSE is a screening tool for cognitive functions impairment.
Measured: up to 4 weeks after brain MRI
Trail Making Test (TMT)
TMT test to determine the executive functions.
Measured: up to 4 weeks after brain MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start30 Dec 2021 (estimated)
- Primary completion30 Apr 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gdansk University of Physical Education and Sport
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Olek, Gdansk University of Physical Education and Sport
- Investigators
- Robert A Olek, PhD, Principal investigator, Gdansk University of Physical Education and Sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03903601
- Sponsor's protocol ID
- DSRiK/10/2019
- Status last verified
- Feb 2021
- First submitted
- 1 Apr 2019
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concentration of Trimethylamine Oxide (TMAO) in Blood Plasma as a Risk Factor for Vascular Cerebral Damage
- ClinicalTrials.gov ID
- NCT03903601
- Acronym / sponsor ID
- DSRiK/10/2019
- Conditions
- Vascular Diseases, Leukoaraiosis, Ischemia, Cerebral
- Keywords
- trimethylamine-N-oxide, magnetic resonance imaging, cognitive functions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Gdansk University of Physical Education and SportUniversity, hospital or other
- Study start
- 30 Dec 2021 (estimated)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 4 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ischemic changes | – | Diagnostic Test: Magnetic Resonance Imaging (MRI), Diagnostic Test: Blood samples collection, Diagnostic Test: Neuropsychological testsPatients with ischemic changes in the brain diagnosed by MRI |
| No ischemic changes | – | Diagnostic Test: Magnetic Resonance Imaging (MRI), Diagnostic Test: Blood samples collection, Diagnostic Test: Neuropsychological testsPatients without ischemic changes in the brain diagnosed by MRI |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from 7th Navy Hospital in Gdansk, which had a brain MRI performed within the past 4 weeks.
Key inclusion criteria (1 listed)
- the ischemic changes in the brain (diagnosed by neurologist by MRI scans)
Key exclusion criteria (1 listed)
- no ischemic changes in the brain (diagnosed by neurologist by MRI scans)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Imaging (MRI)Magnetic Resonance Imaging (MRI) to diagnose ischemic changes in the brain. | Diagnostic test | Ischemic changes, No ischemic changes |
| Blood samples collectionTrimethylamine N-oxide (TMAO) concentration, oxidative stress markers and endothelial dysfunction markers will be determined in blood samples. | Diagnostic test | Ischemic changes, No ischemic changes |
| Neuropsychological testsCognitive functions assessment | Diagnostic test | Ischemic changes, No ischemic changes |
Primary outcome
Brain Magnetic Resonance Imaging (MRI)
Time frame: 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
Time frame: 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.
3 secondary outcomes
Brain-derived neurotrophic factor (BDNF)
Time frame: up to 4 weeks after brain MRI
Mini Mental State Examination (MMSE)
Time frame: up to 4 weeks after brain MRI
Trail Making Test (TMT)
Time frame: up to 4 weeks after brain MRI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert A Olek, PhD principal investigator
Gdansk University of Physical Education and Sport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Diseases and Leukoaraiosis, run by Gdansk University of Physical Education and Sport at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert A Olek, PhD (58 5547392 ext. +48, robol@awf.gda.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain Magnetic Resonance Imaging (MRI) (time frame: before qualifying for the study, during the recruitment period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2021.