Essential HypertensionNCT01938911
The Effects of Social Support and Oxytocin Administration on Physiological Stress Reactivity in Essential Hypertension
A study testing Syntocinon-Spray and Social support in people with Essential Hypertension, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Syntocinon-Spray and Social support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2014to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- rheumatic diseases
- HIV
- cancer
- psychiatric and neurological diseases
- current infectious diseases
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Essential Hypertension
- Being tested
- Syntocinon-Spray, Placebo of syntocinon, Social support
- Keywords
- Trier social stress test, Oxytocin, Hypertension
- Medical subject headings
- Essential Hypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Syntocinon-SprayDrug
Intranasal oxytocin (24 IU)
Placebo of syntocinonDrug
Intranasal administration
Social supportBehavioural
Social support from the best friend
| Study group | Role | What they receive |
|---|---|---|
| Hypertensives with oxytocin and social support | Experimental | 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. Receives: Drug: Syntocinon-Spray; Behavioral: Social support |
| Hypertensives with oxytocin without social support | Experimental | 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. Receives: Drug: Syntocinon-Spray |
| Hypertensives without oxytocin with social support | Experimental | 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. Receives: Drug: Placebo of syntocinon; Behavioral: Social support |
| Hypertensives without oxytocin or social support | Placebo comparator | 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. Receives: Drug: Placebo of syntocinon |
| Normotensives with oxytocin and social support | Experimental | 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. Receives: Drug: Syntocinon-Spray; Behavioral: Social support |
| Normotensives with oxytocin without social support | Experimental | 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. Receives: Drug: Syntocinon-Spray |
| Normotensives without oxytocin with social support | Experimental | 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. Receives: Drug: Placebo of syntocinon; Behavioral: Social support |
| Normotensives without oxytocin or social support | Placebo comparator | 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. Receives: Drug: Placebo of syntocinon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lipids from baseline
Measured: At 110 minutes
Secondary outcomes (4)
Change in lipids from baseline
Measured: At 45, 80, 120, 130, and 170 minutes
Change in catecholamines from baseline
Measured: At 45, 80, 110, 120, 130, 140, 155, and 170 minutes
Change in cortisol from baseline
Measured: At 45, 80, 110, 120, 130, 140, 155, 170, 200, and 230 minutes
Change in cytokine level from baseline
Measured: At 45, 80, 110, 120, 200, and 230 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study startNov 2014
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: PI moved away from Bern; lack of personnel in Bern to conduct the study within a reasonable time frame.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern
- Responsible party
- Sponsor
- Investigators
- Petra Wirtz, Prof. Dr., Study chair, University of Konstanz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01938911
- Sponsor's protocol ID
- 215/10
- Status last verified
- Jan 2019
- First submitted
- 5 Sep 2013
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Social Support and Oxytocin Administration on Physiological Stress Reactivity in Essential Hypertension
- ClinicalTrials.gov ID
- NCT01938911
- Acronym / sponsor ID
- 215/10
- Conditions
- Essential Hypertension
- Keywords
- Trier social stress test, Oxytocin, Hypertension
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI moved away from Bern; lack of personnel in Bern to conduct the study within a reasonable time frame.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University of Bern
- Study start
- Nov 2014 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 10 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Hypertensives with oxytocin and social support | Experimental | Drug: Syntocinon-Spray, Behavioral: Social support80 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. |
| Hypertensives with oxytocin without social support | Experimental | Drug: Syntocinon-Spray80 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. |
| Hypertensives without oxytocin with social support | Experimental | Drug: Placebo of syntocinon, Behavioral: Social support80 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. |
| Hypertensives without oxytocin or social support | Placebo comparator | Drug: Placebo of syntocinon80 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. |
| Normotensives with oxytocin and social support | Experimental | Drug: Syntocinon-Spray, Behavioral: Social support80 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. |
| Normotensives with oxytocin without social support | Experimental | Drug: Syntocinon-Spray80 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. |
| Normotensives without oxytocin with social support | Experimental | Drug: Placebo of syntocinon, Behavioral: Social support80 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. |
| Normotensives without oxytocin or social support | Placebo comparator | Drug: Placebo of syntocinon80 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Syntocinon-SprayIntranasal oxytocin (24 IU) | Drug | Hypertensives with oxytocin and social support, Hypertensives with oxytocin without social support, Normotensives with oxytocin and social support, Normotensives with oxytocin without social support |
| Placebo of syntocinonIntranasal administration | Drug | Hypertensives without oxytocin or social support, Hypertensives without oxytocin with social support, Normotensives without oxytocin or social support, Normotensives without oxytocin with social support |
| Social supportSocial support from the best friend | Behavioural | Hypertensives with oxytocin and social support, Hypertensives without oxytocin with social support, Normotensives with oxytocin and social support, Normotensives without oxytocin with social support |
Primary outcome
Change in lipids from baseline
Time frame: At 110 minutes
4 secondary outcomes
Change in lipids from baseline
Time frame: 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
Change in cortisol from baseline
Time frame: 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
Results and safety
The study was stopped early (reason given: PI moved away from Bern; lack of personnel in Bern to conduct the study within a reasonable time frame.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Clinical Trial of effects of social support and oxytocin on physiological stress reactivity in essential hypertensionLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petra Wirtz, Prof. Dr. study chair
University of Konstanz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Syntocinon-Spray and Social support in people with Essential Hypertension, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI moved away from Bern; lack of personnel in Bern to conduct the study within a reasonable time frame.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lipids from baseline (time frame: At 110 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019.