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临床试验/NCT03900338
NCT03900338已完成不适用

Intestinal Microbiota and Its Relationship With Vascular Structure and Function and Cardiovascular Risk, Phase I (MIVAS Study)

Fundacion para la Investigacion y Formacion en Ciencias de la Salud2 个研究点 分布在 2 个国家目标入组 181 人开始时间: 2019年4月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
181
试验地点
2
主要终点
Pulse wave velocity

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with more than 40 years old who agree to participate in the study and do not meet any of the exclusion criteria.

排除标准

  • 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,

结局指标

主要结局

Pulse wave velocity

时间窗: 1 year

Measurement by SphygmoCor System (meters/seg)

次要结局

  • Carotid intima-media thickness(1 year)
  • Cardio ankle vascular index(1 year)

研究者

发起方
Fundacion para la Investigacion y Formacion en Ciencias de la Salud
申办方类型
Other
责任方
Sponsor

研究点 (2)

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