Clinical trial NCT06222073: Getting Under the Skin of the Menopausal Hot Flush
Official title: The Menopausal Hot Flush: Cutaneous Vascular and Sudomotor Function and Structure in Symptomatic Women
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Menopause
Keywords: hot flush
skin
blood flow
sweating
structure
function
Lead sponsor: Liverpool John Moores University
Sponsor class: OTHER
Collaborators: name: British Heart Foundation
First posted: 2024-01-24
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 24 postmenopausal women (12 who experience hot flushes and 12 who do not) and 12 premenopausal women will be recruited for this study.

Postmenopausal participants (aged \>45 years) will be required to be amenorrhoeic for at least six months and symptomatic women should be experiencing at least four hot flushes per day. Premenopausal women will be eumenorrhoeic and will be aged 18-30 yrs. Participants will be healthy and free from cardiovascular and metabolic risk factors or diseases, and not taking any treatments to alleviate hot flushes. Participants will be required to complete a health screening questionnaire to confirm they are eligible to participate in the study.

Brief summary: The aim of this research is to 1) test how the skin blood vessels and sweat glands function in women who experience hot flushes by using skin microdialysis to deliver small amounts of substances to the skin that cause increased skin blood flow and sweating, and 2) examine the structure of the skin blood vessels and sweat glands in the skin of women who experience hot flushes by taking a very small skin biopsy. Any changes in the function or structure of the skin blood vessels or sweat glands in women with hot flushes would increase our understanding of what causes hot flushes and help to design effective treatments.

Detailed description: In a cross-sectional design, participants will attend the laboratory on two separate occasions. At visit 1, anthropometric measurements will be recorded and a venous blood sample will be collected to determine hormone status (e.g. oestradiol level) and pro-inflammatory markers (e.g. IL-8, Prostaglandin 2E). Participants will then undergo assessment of post-ganglionic skin blood vessel and sweat gland responsiveness (transdermal/cutaneous microdialysis). At visit 2 (\~7 days later), participants will undergo a skin punch biopsy.

Eligibility criteria: Inclusion Criteria:

* Aged \>45 years for the postmenopausal cohort and aged 18-30 years for the premenopausal cohort
* Female
* Amenorrhoeic for \>6 months (postmenopausal criteria)
* \>4 hot flushes per day (symptomatic postmenopausal criteria)
* Eumenorrhoeic with regular menstrual cycles (premenopausal criteria)
* Healthy
* Non-smoker
* BMI 18-30 kg/m2
* No history of cardiovascular or respiratory disease
* No history of metabolic disease e.g. type II diabetes
* Drink \<14 units of alcohol per week
* Not taking any medication or treatments to alleviate hot flushes

Exclusion Criteria:

* Aged \< 18 years or 31-44 years
* Male
* Smokers
* Medical history of cardiovascular/respiratory disease
* Medical history of metabolic disease e.g. type II diabetes
* Drink \>15 units of alcohol per week
* On medication or treatments to alleviate hot flushes or have taken such medication/treatment within the previous 6 months
* BMI of \<18 or \>30 kg/m2
* Vaccination (\<1 week) due to induced systemic inflammatory reaction
* Local forearm infection
* Allergy to local anaesthetic/Marcain/amide-group anaesthetics
* Pregnant

Primary outcomes:
measure: Skin function/responsiveness
timeFrame: Baseline (visit 1)
measure: Sweat gland function/responsiveness
timeFrame: Baseline (visit 1)
measure: Oestradiol
timeFrame: Baseline (visit 1)
measure: Interleukin-6 (IL-6)
timeFrame: Baseline (visit 1)
measure: Interleukin-8 (IL-8)
timeFrame: Baseline (visit 1)
measure: Tumour Necrosis Factor alpha (TNF-α)
timeFrame: Baseline (visit 1)
measure: Prostaglandin E2
timeFrame: Baseline (visit 1)
measure: C-reactive Protein (CRP)
timeFrame: Baseline (visit 1)
measure: Calcitonin Gene Related Peptide (CGRP)
timeFrame: Baseline (visit 1)
measure: Skin structure (blood vessels)
timeFrame: Baseline (visit 2)
measure: Skin structure (sweat glands)
timeFrame: Baseline (visit 2)
Secondary outcomes:
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Liverpool John Moores University
state: Merseyside
Study officials:
affiliation: Liverpool John Moores University
name: Kirsty A. Roberts, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Liverpool John Moores University
name: David A Low, PhD
role: PRINCIPAL_INVESTIGATOR
References: