Roberts Kirsty A, Doyle Abigail, Jones Helen, Low David A
Research Institute for Sport and Exercise Science, Liverpool John Moores University, Liverpool, United Kingdom.
Liverpool Centre for Cardiovascular Science at University of Liverpool, Liverpool John Moores University and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom.
Front Glob Womens Health. 2025 Aug 4;6:1514960. doi: 10.3389/fgwh.2025.1514960. eCollection 2025.
The major pathophysiological symptom of the menopause affecting daily life is hot flushes, which are also associated with elevated cardiovascular disease risk. A hot flush is a sudden and intense heat sensation causing skin flushing and profuse sweating. Menopause-induced oestrogen deficiency could increase the sensitivity of skin blood vessels and sweat glands in postmenopausal women, which could result in more frequent and larger increases in skin blood flow in postmenopausal women consistent with hot flushes. Furthermore, oestrogen withdrawal could also alter the structure of the skin blood vessels and/or sweat glands which may also contribute to hot flushes. This trial aims to examine the function and structure of skin blood vessels and sweat glands in premenopausal and postmenopausal women.
This is a single-centre multi-cohort observational study. Participants will attend the laboratory at Liverpool John Moores University (LJMU) on two separate occasions, ∼7 days apart. Visit 1 will consist of anthropometry, a blood sample and assessment of post-ganglionic skin blood vessel and sweat gland responsiveness via cutaneous microdialysis. At visit 2, participants will return for a skin punch biopsy. A between groups statistical analysis of the pre- and postmenopausal cohorts will be conducted in a blinded manner.
The trial was approved by the North West - Greater Manchester South Research Ethics Committee (22/NW/0300) in the UK. The study adheres to The Declaration of Helsinki and is being conducted in accordance with the UK Policy Framework for Health and Social Care Research.
Identifying functional and/or structural changes in skin blood vessels or sweat glands in women with hot flushes would increase our understanding of their cause(s) and side effects, and help to design effective treatments, including interventions that can manipulate the activity of the skin blood vessels and/or sweat glands via pharmacological or non-pharmacological methods.
NCT06222073.
影响日常生活的更年期主要病理生理症状是潮热，这也与心血管疾病风险升高有关。潮热是一种突然而强烈的热感，会导致皮肤潮红和大量出汗。更年期引起的雌激素缺乏会增加绝经后女性皮肤血管和汗腺的敏感性，这可能导致绝经后女性皮肤血流量更频繁、更大幅度地增加，与潮热相符。此外，雌激素撤退也可能改变皮肤血管和/或汗腺的结构，这也可能导致潮热。本试验旨在研究绝经前和绝经后女性皮肤血管和汗腺的功能及结构。
这是一项单中心多队列观察性研究。参与者将分两次前往利物浦约翰摩尔大学（LJMU）的实验室，两次访问间隔约7天。第一次访问将包括人体测量、采集血样以及通过皮肤微透析评估节后皮肤血管和汗腺的反应性。在第二次访问时，参与者将返回进行皮肤打孔活检。将以盲法对绝经前和绝经后队列进行组间统计分析。
该试验已获得英国西北 - 大曼彻斯特南部研究伦理委员会（22/NW/0300）的批准。该研究遵循《赫尔辛基宣言》，并按照英国健康与社会护理研究政策框架进行。
确定潮热女性皮肤血管或汗腺的功能和/或结构变化，将增进我们对其病因和副作用的理解，并有助于设计有效的治疗方法，包括通过药理学或非药理学方法操纵皮肤血管和/或汗腺活动的干预措施。
NCT06222073。
