The Effects of Social Support and Oxytocin Administration on Physiological Stress Reactivity in Essential Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change in lipids from baseline
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
- •psychiatric and neurological diseases
- •current infectious diseases
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Syntocinon-Spray (Drug)
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.
干预措施: Social support (Behavioral)
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.
干预措施: Syntocinon-Spray (Drug)
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.
干预措施: Placebo of syntocinon (Drug)
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.
干预措施: Social support (Behavioral)
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.
干预措施: Placebo of syntocinon (Drug)
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.
干预措施: Syntocinon-Spray (Drug)
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.
干预措施: Social support (Behavioral)
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.
干预措施: Syntocinon-Spray (Drug)
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.
干预措施: Placebo of syntocinon (Drug)
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.
干预措施: Social support (Behavioral)
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.
干预措施: Placebo of syntocinon (Drug)
结局指标
主要结局
Change in lipids from baseline
时间窗: At 110 minutes
次要结局
- Change in lipids from baseline(At 45, 80, 120, 130, and 170 minutes)
- Change in catecholamines from baseline(At 45, 80, 110, 120, 130, 140, 155, and 170 minutes)
- Change in cortisol from baseline(At 45, 80, 110, 120, 130, 140, 155, 170, 200, and 230 minutes)
- Change in cytokine level from baseline(At 45, 80, 110, 120, 200, and 230 minutes)