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

Endothelial Function Clinical Trial

— PAN  

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01713374
• Other study ID #: PAN-1
• Status: Completed
• Phase: N/A
• First received: October 18, 2012
• Last updated: March 31, 2015
• Start date: October 2012
• Est. completion date: March 2014

Study information

• Verified date: March 2015
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• any active disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Endothelial Function

Intervention

Procedure:
• Mental stress
Subjects will be asked to perform complex mathematic operations at a very fast pace

Other:
• no intervention
control visit

Procedure:
• 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.
• Cold pressure test
A hand will be placed in ice-cold water.

Locations

Country	Name	City	State
Germany	University Medical Center Mainz	Mainz	Rheinland Pfalz

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in FMD in response to sympathetic activation	Flow-mediated dilation will be measured at rest and during each of the interventions.	Change in FMD before versus 1 Minute after begin of intervention	No
Secondary	Change in FMC during sympathetic activation	Change in Flow-mediated constriction induced by each of the interventions.	Change in FMC before versus 1 minute after begin of each intervention	No