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

Primary Purpose

Essential Hypertension

Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Syntocinon-Spray
Placebo of syntocinon
Social support
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension focused on measuring Trier social stress test, Oxytocin, Hypertension

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Psychology, University of Bern

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Hypertensives with oxytocin and social support

Hypertensives with oxytocin without social support

Hypertensives without oxytocin with social support

Hypertensives without oxytocin or social support

Normotensives with oxytocin and social support

Normotensives with oxytocin without social support

Normotensives without oxytocin with social support

Normotensives without oxytocin or social support

Arm Description

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.

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.

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in lipids from baseline

Secondary Outcome Measures

Change in lipids from baseline
Change in catecholamines from baseline
Change in cortisol from baseline
Change in cytokine level from baseline

Full Information

First Posted
September 5, 2013
Last Updated
January 14, 2019
Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
University of Bern
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1. Study Identification

Unique Protocol Identification Number
NCT01938911
Brief Title
The Effects of Social Support and Oxytocin Administration on Physiological Stress Reactivity in Essential Hypertension
Official Title
The Effects of Social Support and Oxytocin Administration on Physiological Stress Reactivity in Essential Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
PI moved away from Bern; lack of personnel in Bern to conduct the study within a reasonable time frame.
Study Start Date
November 2014 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
University of Bern

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
Keywords
Trier social stress test, Oxytocin, Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypertensives with oxytocin and social support
Arm Type
Experimental
Arm Description
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.
Arm Title
Hypertensives with oxytocin without social support
Arm Type
Experimental
Arm Description
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.
Arm Title
Hypertensives without oxytocin with social support
Arm Type
Experimental
Arm Description
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.
Arm Title
Hypertensives without oxytocin or social support
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Normotensives with oxytocin and social support
Arm Type
Experimental
Arm Description
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.
Arm Title
Normotensives with oxytocin without social support
Arm Type
Experimental
Arm Description
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.
Arm Title
Normotensives without oxytocin with social support
Arm Type
Experimental
Arm Description
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.
Arm Title
Normotensives without oxytocin or social support
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Syntocinon-Spray
Intervention Description
Intranasal oxytocin (24 IU)
Intervention Type
Drug
Intervention Name(s)
Placebo of syntocinon
Intervention Description
Intranasal administration
Intervention Type
Behavioral
Intervention Name(s)
Social support
Intervention Description
Social support from the best friend
Primary Outcome Measure Information:
Title
Change in lipids from baseline
Time Frame
At 110 minutes
Secondary Outcome Measure Information:
Title
Change in lipids from baseline
Time Frame
At 45, 80, 120, 130, and 170 minutes
Title
Change in catecholamines from baseline
Time Frame
At 45, 80, 110, 120, 130, 140, 155, and 170 minutes
Title
Change in cortisol from baseline
Time Frame
At 45, 80, 110, 120, 130, 140, 155, 170, 200, and 230 minutes
Title
Change in cytokine level from baseline
Time Frame
At 45, 80, 110, 120, 200, and 230 minutes

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petra Wirtz, Prof. Dr.
Organizational Affiliation
University of Konstanz
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Psychology, University of Bern
City
Bern
ZIP/Postal Code
3012
Country
Switzerland

12. IPD Sharing Statement

Links:
URL
http://www.bioges.psy.unibe.ch/forschung/psychokardiologie/
Description
Clinical Trial of effects of social support and oxytocin on physiological stress reactivity in essential hypertension

Learn more about this trial

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

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