MIVAS: Intestinal Microbiota and Arterial Stiffness

Sponsor

Fundacion para la Investigacion y Formacion en Ciencias de la Salud (Other)

Overall Status

Completed

CT.gov ID

NCT03900338

Collaborator

Castilla-León Health Service (Other)

181

Enrollment

Locations

20.9

Actual Duration (Months)

90.5

Patients Per Site

4.3

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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

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 :

Apr 3, 2019

Actual Primary Completion Date :

Dec 30, 2020

Actual Study Completion Date :

Dec 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
PWV>10 Patients with PWV > 10 (SSphygmoCor) in two different measurements
PWV<10 Patients with PWV < 10 (SphygmoCor) in two different measurements

Outcome Measures

Primary Outcome Measures

Pulse wave velocity [1 year]
Measurement by SphygmoCor System (meters/seg)

Secondary Outcome Measures

Cardio ankle vascular index [1 year]
Measurement by Vasera device 2000 (not units)
Carotid intima-media thickness [1 year]
Measurement by Ultrasonography (Sonosite Micromax) (mm)

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.

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

Locations

	Site	City	State	Country	Postal Code
1	Life and Health Sciences Research Institute in Minho University	Braga		Portugal	4700
2	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

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