Clinical trial NCT03900338: Intestinal Microbiota and Arterial Stiffness
Official title: Intestinal Microbiota and Its Relationship With Vascular Structure and Function and Cardiovascular Risk, Phase I (MIVAS Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arterial Stiffness
Dysbiosis
Keywords: pulse wave velocity
intestinal microbiota
cardiovascular disease
short chain fatty acids
multicentric study
Lead sponsor: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Sponsor class: OTHER
Collaborators: name: Castilla-León Health Service
First posted: 2019-04-03
Enrollment: 181
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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

Eligibility 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,

Primary outcomes:
measure: Pulse wave velocity
timeFrame: 1 year
Secondary outcomes:
measure: Cardio ankle vascular index
timeFrame: 1 year
measure: Carotid intima-media thickness
timeFrame: 1 year
Other outcomes:
Locations:
city: Braga
country: Portugal
facility: Life and Health Sciences Research Institute in Minho University
city: Salamanca
country: Spain
facility: Primary Care Research Unit - The Alamedilla Center for Health
Study officials:
affiliation: rimary Care Research Unit - The Alamedilla Center for Health
name: Luis Garcia-Ortiz
role: STUDY_DIRECTOR
affiliation: rimary Care Research Unit - The Alamedilla Center for Health
name: Rita Salvado Martins
role: PRINCIPAL_INVESTIGATOR
affiliation: Life and Health Sciences Research Institute in Minho University
name: Pedro Guimaraes Cunha
role: STUDY_DIRECTOR
References:
citation: 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.