A Longitudinal Study to Identify Mechanisms of Menopause on Cardiovascular Disease Risk
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age40-61
SponsorUniversity of Copenhagen
About this trial
With the cessation of estrogen production at menopause, the risk of cardiovascular disease like arthrosclerosis, myocardial infarction and stroke increases dramatically. Physical activity is the single most powerful "drug" for maintaining and improving cardiovascular health, but recent data suggest that the positive effect of physical activity is lost at menopause. In this project the investigators will follow a cohort of 200 women from before the women enter menopause and until at least 10 years past menopause. By advanced invasive methodologies the investigators will monitor the changes that occur in the blood vessels of the circulation, the heart and the brain and combine this with microRNA sequencing of blood and tissue samples.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Normal ECG
Regular menstruation
Disqualifiers
Participation in other clinical projects
Smokes or has smoked within the last 10 years
On hormone therapy
Has chronic diseases that are not expected, cf. the groups sought. Including heart problems, atrial fibrillation, cancer, immune diseases and previous strokes with functionally significant sequelae
Trial population
Healthy women between 40-61 years of age, who are menstruating regularly, but that are close to the menopause ( will be estimated through hormonal levels). It is anticipated that the population will have different physical activity levels, and the population will thus be stratified from this, to investigate the role of different habitual physical activity level.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Invasive vascular function
Changes in vascular function across the menopausal transition (pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause Vascular function is assessed by intra-arterial infusions of acetylcholine and epoprostenol) in the brachial artery using ultrasound doppler
Time frame
pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause2
Non-invasive vascular function
Changes in vascular function across the menopausal transition (pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause Vascular function is assessed by flow-mediated dilation (FMD) in the brachial artery using ultrasound doppler
Time frame
pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopauseSecondary outcomes
1
Changes in skeletal muscle expression of protein
Changes in skeletal muscle expression of protein across the menopausal transition, and with different physical activity levels. (pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause Western blots will be used to determine endothelial nitric oxide synthase (eNOS), cyclo-oxygenase 1 and 2, prostacyclin synthase, endothelin receptor A and B, VEGF (vascular endothelial growth factor), Thrombospondin-1, Flk-1 (VEGF receptor). All protein content measures will be presented as arbitrary units.
Time frame
pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause2
Changes in skeletal muscle and blood sample expression of RNA
Changes in skeletal muscle and blood sample expression of RNA across the menopausal transition, and with different physical activity levels. (pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause. RNA sequencing will be used to determine changes in RNA profile, with specific focus on microRNA.
Time frame
pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause3
Blood pressure
Changes in blood pressure across the menopausal transition
Time frame
pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopauseSponsors and contacts
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Source ClinicalTrials.gov