Arterial StiffnessMIVASNCT03900338
Intestinal Microbiota and Arterial Stiffness
An observational study of Arterial Stiffness and Dysbiosis, run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud at 2 sites in 2 countries.
Trial summary
This is an observational case-control study which objective is to analyse differences in intestinal microbiota between patients with and without arterial stiffness, measured by pulse wave velocity. It will take place in two different research units located in Portugal and Spain. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Arterial Stiffness, Dysbiosis
- How many people
- 181 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 3 Apr 2019to 30 Dec 2020
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The investigators will select 324 subjects, between 40 to 75 years-old, from a database that combine data from four different studies: Triple A, EVA and Mark that took place in the Research Unit of La Alamedilla Primary Care Center, and Guimarães/ Vizela Study promoted by the Life and Health Sciences Research Institute in Minho University. The 162 cases with a pathologic pulse wave velocity will be randomly selected, each of this subjects will be matched to an individual with the same or similar propensity score. Each one of these subjects will go through a PWV study to confirm that they're in the right group.
Who may be able to join
- Patients with more than 40 years old who agree to participate in the study and do not meet any of the exclusion criteria.
Who cannot join
- Participants who are in terminal condition,
- Participants with a history of cardiovascular disease (ischaemic heart disease or stroke, peripheral arterial disease or Heart Failure),
- People with diabetes,
- diagnosed renal failure in terminal stages (glomerular filtration rate below 30%),
- chronic inflammatory disease or acute inflammatory process in the past 3 months.
- Patients treated with oestrogens, testosterone or growth hormone,
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Portugal1 site
Life and Health Sciences Research Institute in Minho University
Braga, 4700
Spain1 site
Primary Care Research Unit - The Alamedilla Center for Health
Salamanca, 37006
About this study
Official title: Intestinal Microbiota and Its Relationship With Vascular Structure and Function and Cardiovascular Risk, Phase I (MIVAS Study)
This is an observational case-control study which objective is to analyse differences in intestinal microbiota between patients with and without arterial stiffness, measured by pulse wave velocity. It will take place in two different research units located in Portugal and Spain.
Read the detailed description
Aim: analyse differences in intestinal microbiota between patients with and without arterial stiffness, measured by pulse wave velocity.
Design and setting: An observational case-control study. Study population: The investigators will select 324 subjects, between 30 to 75 years-old, from a database that combine data from four different studies: Triple A, Early vascular Aging (EVA) and Improving interMediAte Risk management (MARK) that took place in the Research Unit of La Alamedilla Primary Care Center, and Guimarães/ Vizela Study promoted by the Life and Health Sciences Research Institute in Minho University.
Measurements: 162 Cases will be defined by a Carotid-femoral Pulse Wave Velocity (cf-PWV)>10 mm/s determined using the SphygmoCor System. 162 controls will be selected by the propensity score. The composition of the gut microbiome in faecal samples will be determined by ribosomal ribonucleic acid (16S rRNA) gene sequencing. Other measurements: demographic data, lifestyle assessment (physical activity, adherence to the Mediterranean diet, alcohol and tobacco consumption). Anthropometric Variables: Weight, body composition by bioimpedance, size, body mass index (BMI), waist and hip perimeter, peripheral and central arterial pressure. Analysis of structure and vascular function and organ lesions target: pulse wave velocity, cardio-ankle vascular index and ankle-brachial index; Intimal median carotid thickness, central and peripheral rate of increase, renal and cardiac organic lesion. Blood analysis: short chain fatty acids, total bile acids, ursodeoxycholic acid
- Conditions
- Arterial Stiffness, Dysbiosis
- Keywords
- pulse wave velocity, intestinal microbiota, cardiovascular disease, short chain fatty acids, multicentric study
- Medical subject headings
- Dysbiosis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PWV>10 | Patients with PWV > 10 (SSphygmoCor) in two different measurements | |
| PWV<10 | Patients with PWV < 10 (SphygmoCor) in two different measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse wave velocity
Measurement by SphygmoCor System (meters/seg)
Measured: 1 year
Secondary outcomes (2)
Cardio ankle vascular index
Measurement by Vasera device 2000 (not units)
Measured: 1 year
Carotid intima-media thickness
Measurement by Ultrasonography (Sonosite Micromax) (mm)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start3 Apr 2019
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Arterial StiffnessStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion y Formacion en Ciencias de la Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Castilla-León Health Service
- Responsible party
- Sponsor
- Investigators
- Luis Garcia-Ortiz, Study director, rimary Care Research Unit - The Alamedilla Center for HealthRita Salvado Martins, Principal investigator, rimary Care Research Unit - The Alamedilla Center for HealthPedro Guimaraes Cunha, Study director, Life and Health Sciences Research Institute in Minho University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900338
- Sponsor's protocol ID
- GRS 1820/B/18
- Acronym
- MIVAS
- Status last verified
- Mar 2021
- First submitted
- 29 Mar 2019
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Salvado R, Lugones-Sanchez C, Santos-Minguez S, Gonzalez-Sanchez S, Quesada JA, Benito R, Rodriguez-Sanchez E, Gomez-Marcos MA, Guimaraes-Cunha P, Hernandez-Rivas JM, Mira A, Garcia-Ortiz L, Mivas Investigators. Sex Differences in Gut Microbiota and Their Relation to Arterial Stiffness (MIVAS Study). Nutrients. 2024 Dec 27;17(1):53. doi: 10.3390/nu17010053.
PubMed 39796488Salvado R, Santos-Minguez S, Agudo-Conde C, Lugones-Sanchez C, Cabo-Laso A, M feminine Hernandez-Sanchez J, Benito R, Rodriguez-Sanchez E, Gomez-Marcos MA, Hernandez-Rivas JM, Guimaraes Cunha P, Garcia-Ortiz L, Investigators M. Gut microbiota composition and arterial stiffness measured by pulse wave velocity: case-control study protocol (MIVAS study). BMJ Open. 2021 Feb 11;11(2):e038933. doi: 10.1136/bmjopen-2020-038933.
PubMed 33574140
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Microbiota and Its Relationship With Vascular Structure and Function and Cardiovascular Risk, Phase I (MIVAS Study)
- ClinicalTrials.gov ID
- NCT03900338
- Acronym / sponsor ID
- MIVAS / GRS 1820/B/18
- Conditions
- Arterial Stiffness, Dysbiosis
- Keywords
- pulse wave velocity, intestinal microbiota, cardiovascular disease, short chain fatty acids, multicentric study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion y Formacion en Ciencias de la SaludUniversity, hospital or other
- Collaborators
- Castilla-León Health Service
- Study start
- 3 Apr 2019 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 3 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.
This is an observational case-control study which objective is to analyse differences in intestinal microbiota between patients with and without arterial stiffness, measured by pulse wave velocity. It will take place in two different research units located in Portugal and Spain.
Detailed description
Aim: analyse differences in intestinal microbiota between patients with and without arterial stiffness, measured by pulse wave velocity.
Design and setting: An observational case-control study. Study population: The investigators will select 324 subjects, between 30 to 75 years-old, from a database that combine data from four different studies: Triple A, Early vascular Aging (EVA) and Improving interMediAte Risk management (MARK) that took place in the Research Unit of La Alamedilla Primary Care Center, and Guimarães/ Vizela Study promoted by the Life and Health Sciences Research Institute in Minho University.
Measurements: 162 Cases will be defined by a Carotid-femoral Pulse Wave Velocity (cf-PWV)>10 mm/s determined using the SphygmoCor System. 162 controls will be selected by the propensity score. The composition of the gut microbiome in faecal samples will be determined by ribosomal ribonucleic acid (16S rRNA) gene sequencing. Other measurements: demographic data, lifestyle assessment (physical activity, adherence to the Mediterranean diet, alcohol and tobacco consumption). Anthropometric Variables: Weight, body composition by bioimpedance, size, body mass index (BMI), waist and hip perimeter, peripheral and central arterial pressure. Analysis of structure and vascular function and organ lesions target: pulse wave velocity, cardio-ankle vascular index and ankle-brachial index; Intimal median carotid thickness, central and peripheral rate of increase, renal and cardiac organic lesion. Blood analysis: short chain fatty acids, total bile acids, ursodeoxycholic acid
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PWV>10 | – | –Patients with PWV > 10 (SSphygmoCor) in two different measurements |
| PWV<10 | – | –Patients with PWV < 10 (SphygmoCor) in two different measurements |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators will select 324 subjects, between 40 to 75 years-old, from a database that combine data from four different studies: Triple A, EVA and Mark that took place in the Research Unit of La Alamedilla Primary Care Center, and Guimarães/ Vizela Study promoted by the Life and Health Sciences Research Institute in Minho University. The 162 cases with a pathologic pulse wave velocity will be randomly selected, each of this subjects will be matched to an individual with the same or similar propensity score. Each one of these subjects will go through a PWV study to confirm that they're in the right group.
Key inclusion criteria (1 listed)
- Patients with more than 40 years old who agree to participate in the study and do not meet any of the exclusion criteria.
Key exclusion criteria (6 listed)
- Participants who are in terminal condition,
- Participants with a history of cardiovascular disease (ischaemic heart disease or stroke, peripheral arterial disease or Heart Failure),
- People with diabetes,
- diagnosed renal failure in terminal stages (glomerular filtration rate below 30%),
- chronic inflammatory disease or acute inflammatory process in the past 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pulse wave velocity
Time frame: 1 year
Measurement by SphygmoCor System (meters/seg)
2 secondary outcomes
Cardio ankle vascular index
Time frame: 1 year
Carotid intima-media thickness
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Derived from this study: PubMed 39796488Salvado R, Lugones-Sanchez C, Santos-Minguez S, Gonzalez-Sanchez S, Quesada JA, Benito R, Rodriguez-Sanchez E, Gomez-Marcos MA, Guimaraes-Cunha P, Hernandez-Rivas JM, Mira A, Garcia-Ortiz L, Mivas Investigators. Sex Differences in Gut Microbiota and Their Relation to Arterial Stiffness (MIVAS Study). Nutrients. 2024 Dec 27;17(1):53. doi: 10.3390/nu17010053.
- Derived from this study: PubMed 33574140Salvado R, Santos-Minguez S, Agudo-Conde C, Lugones-Sanchez C, Cabo-Laso A, M feminine Hernandez-Sanchez J, Benito R, Rodriguez-Sanchez E, Gomez-Marcos MA, Hernandez-Rivas JM, Guimaraes Cunha P, Garcia-Ortiz L, Investigators M. Gut microbiota composition and arterial stiffness measured by pulse wave velocity: case-control study protocol (MIVAS study). BMJ Open. 2021 Feb 11;11(2):e038933. doi: 10.1136/bmjopen-2020-038933.
- Individual participant dataSharing planned: No
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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.
Luis Garcia-Ortiz study director
rimary Care Research Unit - The Alamedilla Center for Health
Rita Salvado Martins principal investigator
rimary Care Research Unit - The Alamedilla Center for Health
Pedro Guimaraes Cunha study director
Life and Health Sciences Research Institute in Minho University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Stiffness and Dysbiosis, run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud at 2 sites in 2 countries.
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 6 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: finished, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal, Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse wave velocity (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03900338, which also lists 2 linked publications.
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 2 Mar 2021.