Physiological Assessment of the Endothelium - Circadian Rhythm and Role of the Sympathetic Nervous System

NCT ID: NCT01713374

Last Updated: 2015-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-03-31

Brief Summary

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The purpose of this study is to determine whether interventions aimed at increasing sympathetic tone modify endothelial function measures as assessed by the measurement of flow-mediated dilation (FMD) and constriction (FMC). The investigators hypothesize that the three interventions under study will increase FMC while causing a blunting in FMD.

Further, the investigators plan to study the circadian variability of FMC and FMD. The investigators hypothesize a peak of FMD in the late hours of the day and a peak of FMC in the early hours.

Detailed Description

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Conditions

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Endothelial Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Myogenic activation

Subjects will undergo endothelial function assessment at rest and, after a 45 minutes pause, 1 minute after begin of myogenic activation

Group Type ACTIVE_COMPARATOR

Myogenic activation

Intervention Type PROCEDURE

A pneumatic cuff will be inflated to suprasystolic pressure around both thighs and the subjects will be asked to perform plantar flexion exercises.

Cold pressure test

Subjects will undergo endothelial function assessment at rest and, after a 45 minutes pause, 1 minute after begin of cold pressure test

Group Type ACTIVE_COMPARATOR

Cold pressure test

Intervention Type PROCEDURE

A hand will be placed in ice-cold water.

mental stress

Subjects will undergo endothelial function assessment at rest and, after a 45 minutes pause, 1 minute after begin of mental stress

Group Type ACTIVE_COMPARATOR

Mental stress

Intervention Type PROCEDURE

Subjects will be asked to perform complex mathematic operations at a very fast pace

Control

Control visit - no intervention performed - subjects will undergo endothelial function measurement twice at a distance of 45 minutes

Group Type ACTIVE_COMPARATOR

no intervention

Intervention Type OTHER

control visit

Interventions

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Mental stress

Subjects will be asked to perform complex mathematic operations at a very fast pace

Intervention Type PROCEDURE

no intervention

control visit

Intervention Type OTHER

Myogenic activation

A pneumatic cuff will be inflated to suprasystolic pressure around both thighs and the subjects will be asked to perform plantar flexion exercises.

Intervention Type PROCEDURE

Cold pressure test

A hand will be placed in ice-cold water.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* healthy volunteers with no cardiovascular risk factor, no current disease, normal laboratory parameters and ECG.

Exclusion Criteria

* any active disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Johannes Gutenberg University Mainz

OTHER

Sponsor Role lead

Responsible Party

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Tommaso Gori

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tommaso Gori, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Mainz

Locations

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University Medical Center Mainz

Mainz, Rhineland-Palatinate, Germany

Site Status

Countries

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Germany

Other Identifiers

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PAN-1

Identifier Type: -

Identifier Source: org_study_id

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