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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01713374
Other study ID # PAN-1
Secondary ID
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


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
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