Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03900338 |
Other study ID # |
GRS 1820/B/18 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
April 3, 2019 |
Est. completion date |
December 30, 2020 |
Study information
Verified date |
March 2021 |
Source |
Fundacion para la Investigacion y Formacion en Ciencias de la Salud |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
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