Skip to main content
OpenTrials
Completed

NCT Number: NCT01713374

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Endothelial Function

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • any active disease

Treatment and study plan

Mental stress

Procedure

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

No intervention

Other

control visit

Myogenic activation

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

Procedure

A hand will be placed in ice-cold water.

Primary outcomes

  1. Change in FMD in response to sympathetic activation

    Time frame: Change in FMD before versus 1 Minute after begin of intervention

    Flow-mediated dilation will be measured at rest and during each of the interventions.

Secondary outcomes

  1. Change in FMC during sympathetic activation

    Time frame: Change in FMC before versus 1 minute after begin of each intervention

    Change in Flow-mediated constriction induced by each of the interventions.

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Registry information

Official study title

Studies on the Physiological Meaning of Flow-mediated Constriction, Flow-mediated Dilatation and Vasomotion/Flowmotion: Circadian Variability and Role of the Sympathetic Nervous System.

Acronym: PAN

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Oct 24, 2012
Registry last updated
Apr 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.