Getting Under the Skin of the Menopausal Hot Flush

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Menopause

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Postmenopausal + Hot Flush (P+HF)

Postmenopausal women who regularly experience hot flushes.

No interventions assigned to this group

Postmenopausal + Hot Flush (P-HF)

Postmenopausal women who do not experience hot flushes.

No interventions assigned to this group

Premenopausal

Premenopausal women who experience regular menstruation.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes