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Intestinal Microbiota and Arterial Stiffness

Intestinal Microbiota and Its Relationship With Vascular Structure and Function and Cardiovascular Risk, Phase I (MIVAS Study)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03900338
Acronym
MIVAS
Enrollment
181
Registered
2019-04-03
Start date
2019-04-03
Completion date
2020-12-30
Last updated
2021-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial Stiffness, Dysbiosis

Keywords

pulse wave velocity, intestinal microbiota, cardiovascular disease, short chain fatty acids, multicentric study

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.

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

Interventions

None listed

Sponsors

Castilla-León Health Service
CollaboratorOTHER
Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes

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

.

Design outcomes

Primary

MeasureTime frameDescription
Pulse wave velocity1 yearMeasurement by SphygmoCor System (meters/seg)

Secondary

MeasureTime frameDescription
Cardio ankle vascular index1 yearMeasurement by Vasera device 2000 (not units)
Carotid intima-media thickness1 yearMeasurement by Ultrasonography (Sonosite Micromax) (mm)

Countries

Portugal, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026