The Effects of Social Support and Oxytocin Administration on Physiological Stress Reactivity in Essential Hypertension

January 14, 2019 updated by: University Hospital Inselspital, Berne
To test a psychopharmacological intervention strategy which may provide new insights into the mechanisms underlying the physiological hyperreactivity to stress observed in hypertension, we plan to test the effects of the neuropeptide oxytocin and social support on the neurobiological and psychological responsiveness to social stress. The study population for this project consists of 80 hypertensive and 80 normotensive non-smoking medication-free men. We expect exogenous oxytocin administration to enable hypertensives to effectively take advantage of the provided social support. Thereby, oxytocin may enhance the effect of social support on reducing the previously observed physiological hyperreactivity to stress in essential hypertensives.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Background

Data on psychobiological stress reactivity in essential hypertension demonstrated physiological hyperreactivity to acute psychosocial stress in hypertensives as compared to normotensive controls in terms of sympathetic nervous system and hypothalamus-pituitary-adrenal axis activity, blood lipids, and coagulation activity. Moreover, we found lower perceived social support in hypertensives as compared to normotensives, with the highest physiological stress responses in hypertensives with low perceived social support.. In addition, the collaborating group of Prof. Heinrichs demonstrated that OT and social support interact to reduce neuroendocrine responses to stress in normotensive individuals. Given these findings and given the aforementioned hypothesized role for OT in physiological stress reactivity, particularly in hypertension, it seems promising to investigate the combined effects of OT and social support provision on physiological stress reactivity in essential hypertensives as compared to normotensives.

Objective

The proposed project will provide new information on neuroendocrine mechanisms underlying the observed physiological hyperreactivity to stress in essential hypertension. Moreover, stress reactivity of intermediate biological risk factors has not yet been investigated in experiments studying the effects of the acutely provided social support, either in healthy individuals or in hypertensives. The results of this project may provide important information for the development of effective interdisciplinary prevention and intervention strategies for essential hypertension

Methods

The methodological approach of social stress induction by the TSST used in our previous hypertension study will be translated to the planned project and we will repeatedly collect blood and saliva samples to measure neuroendocrine reactivity in terms of cortisol, epinephrine, and norepinephrine, as well as continuously measuring of heart rate and blood pressure. Blood pressure will be measured at each sampling timepoint as well as twice during the TSST (during the speech and during mental arithmetics). As our recent findings suggest strong associations between social support and heightened coagulation activity in healthy subjects before and after social stress, and as we found higher lipid and coagulation reactivity to psychosocial stress in hypertensives with catecholamine stress changes predicting elevated lipid stress reactivity, we plan to additionally measure biological risk factors for CHD.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3012
        • Department of Psychology, University of Bern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • aged between 18 and 80 years
  • sufficient knowledge of German language in reading and understanding
  • medication-free
  • non-smoking
  • systolic blood pressure ≥ 140 < 180 mmHg and/or diastolic blood pressure ≥ 90 < 110 mmHg for the hypertension group
  • systolic blood pressure < 140 mmHg and diastolic blood pressure < 90 mmHg for the normotensive control
  • written informed consent

Exclusion Criteria

  • any alcohol, caffeine, and theine consumption 24 hours before the experiment
  • regular strenuous exercise
  • alcohol and illicit drug abuse
  • liver and renal diseases
  • chronic obstructive pulmonary disease
  • allergies and atopic diathesis
  • rheumatic diseases
  • HIV
  • cancer
  • psychiatric and neurological diseases
  • current infectious diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Hypertensives with oxytocin and social support
80 hypertensive non-smoking medication-free men will be randomly assigned to receive intranasal OT (24 IU) or placebo 50 min before stress, and either social support (SS) from their best friend during the preparation period of the stress protocol or no social support.
Drug: Syntocinon-Spray
Intranasal oxytocin (24 IU)
Behavioral: Social support
Social support from the best friend
EXPERIMENTAL: Hypertensives with oxytocin without social support
80 normotensive non-smoking medication-free men will be randomly assigned to receive intranasal OT (24 IU) or placebo 50 min before stress, and either social support (SS) from their best friend during the preparation period of the stress protocol or no social support.
Drug: Syntocinon-Spray
Intranasal oxytocin (24 IU)
EXPERIMENTAL: Hypertensives without oxytocin with social support
80 hypertensive non-smoking medication-free men will be randomly assigned to receive intranasal OT (24 IU) or placebo 50 min before stress, and either social support (SS) from their best friend during the preparation period of the stress protocol or no social support.
Behavioral: Social support
Social support from the best friend
Drug: Placebo of syntocinon
Intranasal administration
PLACEBO_COMPARATOR: Hypertensives without oxytocin or social support
80 hypertensive non-smoking medication-free men will be randomly assigned to receive intranasal OT (24 IU) or placebo 50 min before stress, and either social support (SS) from their best friend during the preparation period of the stress protocol or no social support.
Drug: Placebo of syntocinon
Intranasal administration
EXPERIMENTAL: Normotensives with oxytocin and social support
80 hypertensive non-smoking medication-free men will be randomly assigned to receive intranasal OT (24 IU) or placebo 50 min before stress, and either social support (SS) from their best friend during the preparation period of the stress protocol or no social support.
Drug: Syntocinon-Spray
Intranasal oxytocin (24 IU)
Behavioral: Social support
Social support from the best friend
EXPERIMENTAL: Normotensives with oxytocin without social support
80 hypertensive non-smoking medication-free men will be randomly assigned to receive intranasal OT (24 IU) or placebo 50 min before stress, and either social support (SS) from their best friend during the preparation period of the stress protocol or no social support.
Drug: Syntocinon-Spray
Intranasal oxytocin (24 IU)
EXPERIMENTAL: Normotensives without oxytocin with social support
80 hypertensive non-smoking medication-free men will be randomly assigned to receive intranasal OT (24 IU) or placebo 50 min before stress, and either social support (SS) from their best friend during the preparation period of the stress protocol or no social support.
Behavioral: Social support
Social support from the best friend
Drug: Placebo of syntocinon
Intranasal administration
PLACEBO_COMPARATOR: Normotensives without oxytocin or social support
80 hypertensive non-smoking medication-free men will be randomly assigned to receive intranasal OT (24 IU) or placebo 50 min before stress, and either social support (SS) from their best friend during the preparation period of the stress protocol or no social support.
Drug: Placebo of syntocinon
Intranasal administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in lipids from baseline
Time Frame: At 110 minutes
At 110 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in lipids from baseline
Time Frame: At 45, 80, 120, 130, and 170 minutes
At 45, 80, 120, 130, and 170 minutes
Change in catecholamines from baseline
Time Frame: At 45, 80, 110, 120, 130, 140, 155, and 170 minutes
At 45, 80, 110, 120, 130, 140, 155, and 170 minutes
Change in cortisol from baseline
Time Frame: At 45, 80, 110, 120, 130, 140, 155, 170, 200, and 230 minutes
At 45, 80, 110, 120, 130, 140, 155, 170, 200, and 230 minutes
Change in cytokine level from baseline
Time Frame: At 45, 80, 110, 120, 200, and 230 minutes
At 45, 80, 110, 120, 200, and 230 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Collaborators

University of Bern

Investigators

  • Study Chair: Petra Wirtz, Prof. Dr., University of Konstanz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2014

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

September 5, 2013

First Submitted That Met QC Criteria

September 5, 2013

First Posted (ESTIMATE)

September 10, 2013

Study Record Updates

Last Update Posted (ACTUAL)

January 16, 2019

Last Update Submitted That Met QC Criteria

January 14, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 215/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe