Intestinal Microbiota and Arterial Stiffness (MIVAS)

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.

Study Overview

• Status: Completed
• Conditions: Dysbiosis; Arterial Stiffness

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 Type: Observational
• Enrollment (Actual): 181

Contacts and Locations

Study Locations

• Portugal
  • Braga, Portugal, 4700
    • Life and Health Sciences Research Institute in Minho University
• Spain
  • Salamanca, Spain, 37006
    • Primary Care Research Unit - The Alamedilla Center for Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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,

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
PWV>10; Patients with PWV > 10 (SSphygmoCor) in two different measurements
PWV<10; Patients with PWV < 10 (SphygmoCor) in two different measurements

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulse wave velocity	Measurement by SphygmoCor System (meters/seg)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardio ankle vascular index	Measurement by Vasera device 2000 (not units)	1 year
Carotid intima-media thickness	Measurement by Ultrasonography (Sonosite Micromax) (mm)	1 year

Collaborators and Investigators

• Sponsor: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
• Collaborators: Castilla-León Health Service
• Investigators: 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

Publications and helpful links

General Publications

• Salvado 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 3, 2019
• Primary Completion (ACTUAL): December 30, 2020
• Study Completion (ACTUAL): December 30, 2020

Study Registration Dates

• First Submitted: March 29, 2019
• First Submitted That Met QC Criteria: April 1, 2019
• First Posted (ACTUAL): April 3, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 2, 2021
• Last Update Submitted That Met QC Criteria: March 1, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: cardiovascular disease; pulse wave velocity; intestinal microbiota; short chain fatty acids; multicentric study
• Additional Relevant MeSH Terms: Pathologic Processes; Dysbiosis
• Other Study ID Numbers: GRS 1820/B/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No