NCT03900338

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
181

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2019

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 3, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

April 3, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

March 2, 2021

Status Verified

March 1, 2021

Enrollment Period

1.7 years

First QC Date

March 29, 2019

Last Update Submit

March 1, 2021

Conditions

Arterial StiffnessDysbiosis

Keywords

pulse wave velocityintestinal microbiotacardiovascular diseaseshort chain fatty acidsmulticentric study

Outcome Measures

Primary Outcomes (1)

  • Pulse wave velocity

    Measurement by SphygmoCor System (meters/seg)

    1 year

Secondary Outcomes (2)

  • Cardio ankle vascular index

    1 year

  • Carotid intima-media thickness

    1 year

Study Arms (2)

PWV>10

Patients with PWV \> 10 (SSphygmoCor) in two different measurements

PWV<10

Patients with PWV \< 10 (SphygmoCor) in two different measurements

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Life and Health Sciences Research Institute in Minho University

Braga, 4700, Portugal

Location

Primary Care Research Unit - The Alamedilla Center for Health

Salamanca, 37006, Spain

Location

Related Publications (2)

  • Salvado R, Lugones-Sanchez C, Santos-Minguez S, Gonzalez-Sanchez S, Quesada JA, Benito R, Rodriguez-Sanchez E, Gomez-Marcos MA, Guimaraes-Cunha P, Hernandez-Rivas JM, Mira A, Garcia-Ortiz L, Mivas Investigators. Sex Differences in Gut Microbiota and Their Relation to Arterial Stiffness (MIVAS Study). Nutrients. 2024 Dec 27;17(1):53. doi: 10.3390/nu17010053.

    PMID: 39796488DERIVED

  • 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.

    PMID: 33574140DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool

MeSH Terms

Conditions

DysbiosisCardiovascular Diseases

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Luis Garcia-Ortiz

    rimary Care Research Unit - The Alamedilla Center for Health

    STUDY DIRECTOR

  • Rita Salvado Martins

    rimary Care Research Unit - The Alamedilla Center for Health

    PRINCIPAL INVESTIGATOR

  • Pedro Guimaraes Cunha

    Life and Health Sciences Research Institute in Minho University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2019

First Posted

April 3, 2019

Study Start

April 3, 2019

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

March 2, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)PT(1)