Getting Under the Skin of the Menopausal Hot Flush
ConditionMenopause
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-60
SponsorLiverpool John Moores University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
Aged < 18 years or 31-44 years
Male
Smokers
Medical history of cardiovascular/respiratory disease
Trial 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.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
36 Participants
are grouped into 3 trial groupsGroup A: Postmenopausal + Hot Flush (P+HF)
Group B: Postmenopausal + Hot Flush (P-HF)
Group C: Premenopausal
Trial outcomes
Primary outcomes
1
Skin function/responsiveness
The non-dominant forearm will be inserted with 3 cutaneous microdialysis membranes. Each of the membranes will be perfused with either of the following (randomly assigned to the three sites); increasing doses of Acetylcholine, Sodium Nitroprusside (SNP) or calcitonin gene-related peptide (CGRP) to stimulate skin blood flow (and sweating) which will be assessed using laser Doppler probes housed directly over the membrane sites. The dose-response curves for skin blood flow will be mathematically modelled via non-linear regression curve fitting. The maximum responses and the effective concentration causing 50% of the maximal response (EC50) will be calculated from the nonlinear regression modelling.
Time frame
Baseline (visit 1)2
Sweat gland function/responsiveness
The non-dominant forearm will be inserted with 3 cutaneous microdialysis membranes. Each of the membranes will be perfused with either of the following (randomly assigned to the three sites); increasing doses of Acetylcholine, Sodium Nitroprusside (SNP) or calcitonin gene-related peptide (CGRP) to stimulate sweating (and skin blood flow) which will be assessed using laser Doppler probes housed directly over the membrane sites. The dose-response curves for sweating will be mathematically modelled via non-linear regression curve fitting. The maximum responses and the effective concentration causing 50% of the maximal response (EC50) will be calculated from the nonlinear regression modelling.
Time frame
Baseline (visit 1)3
Oestradiol
A venous blood sample will be taken and analysed to establish the oestradiol level (pg/mL).
Time frame
Baseline (visit 1)4
Interleukin-6 (IL-6)
A venous blood sample will be taken to assess circulating inflammatory markers/cytokines. Interleukin-6 (IL-6) will be measured (pg/mL) using an ELISA.
Time frame
Baseline (visit 1)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Liverpool John Moores University
Lead sponsor
British Heart Foundation
Collaborator
Source ClinicalTrials.gov