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Intestinal Microbiota and Arterial Stiffness (MIVAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03900338
Recruitment Status : Completed
First Posted : April 3, 2019
Last Update Posted : March 2, 2021
Sponsor:
Collaborator:
Castilla-León Health Service
Information provided by (Responsible Party):
Fundacion para la Investigacion y Formacion en Ciencias de la Salud

Study Description
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Brief 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.

Condition or disease
Arterial Stiffness Dysbiosis

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
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Study Type : Observational
Actual Enrollment : 181 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Intestinal Microbiota and Its Relationship With Vascular Structure and Function and Cardiovascular Risk, Phase I (MIVAS Study)
Actual Study Start Date : April 3, 2019
Actual Primary Completion Date : December 30, 2020
Actual Study Completion Date : December 30, 2020
Groups and Cohorts
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Group/Cohort
PWV>10
Patients with PWV > 10 (SSphygmoCor) in two different measurements
PWV<10
Patients with PWV < 10 (SphygmoCor) in two different measurements


Outcome Measures
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Primary Outcome Measures :
  1. Pulse wave velocity [ Time Frame: 1 year ]
    Measurement by SphygmoCor System (meters/seg)


Secondary Outcome Measures :
  1. Cardio ankle vascular index [ Time Frame: 1 year ]
    Measurement by Vasera device 2000 (not units)

  2. Carotid intima-media thickness [ Time Frame: 1 year ]
    Measurement by Ultrasonography (Sonosite Micromax) (mm)


Biospecimen Retention:   Samples Without DNA
Stool

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.

Criteria

Inclusion Criteria:

• Patients with more than 40 years old who agree to participate in the study and do not meet any of the exclusion criteria.

Exclusion Criteria:

  • 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,
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03900338


Locations
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Portugal
Life and Health Sciences Research Institute in Minho University
Braga, Portugal, 4700
Spain
Primary Care Research Unit - The Alamedilla Center for Health
Salamanca, Spain, 37006
Sponsors and Collaborators
Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Castilla-León Health Service
Investigators
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Study Director: Luis Garcia-Ortiz rimary Care Research Unit - The Alamedilla Center for Health
Principal Investigator: Rita Salvado Martins rimary Care Research Unit - The Alamedilla Center for Health
Study Director: Pedro Guimaraes Cunha Life and Health Sciences Research Institute in Minho University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
ClinicalTrials.gov Identifier: NCT03900338    
Other Study ID Numbers: GRS 1820/B/18
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: March 2, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundacion para la Investigacion y Formacion en Ciencias de la Salud:
pulse wave velocity
intestinal microbiota
cardiovascular disease
short chain fatty acids
multicentric study
Additional relevant MeSH terms:
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Dysbiosis
Pathologic Processes