Intestinal Microbiota and Arterial Stiffness

Completed

• Conditions: Dysbiosis; Arterial Stiffness

• Registration Number: NCT03900338
• Lead Sponsor: Fundacion para la Investigacion y Formacion en Ciencias de la Salud

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

Study Timeline

• Study First Submitted: 2019-03-29
• Study First Submitted QC: 2019-04-01
• Study Start: 2019-04-03
• Study First Posted: 2019-04-03
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-01
• Last Update Posted: 2021-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 181

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pulse wave velocity	1 year	Measurement by SphygmoCor System (meters/seg)

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Life and Health Sciences Research Institute in Minho University; 🇵🇹 Braga, Portugal

Primary Care Research Unit - The Alamedilla Center for Health; 🇪🇸 Salamanca, Spain