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A Longitudinal Study to Identify Mechanisms of Menopause on Cardiovascular Disease Risk

A Longitudinal Study to Identify Mechanisms of Menopause on Cardiovascular Disease Risk

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05647876
Enrollment
200
Registered
2022-12-13
Start date
2022-12-16
Completion date
2045-08-31
Last updated
2023-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Menopause, Physical Activity, Vascular Dilation

Brief summary

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.

Interventions

None listed

Sponsors

University of Copenhagen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 61 Years
Healthy volunteers
Yes

Inclusion criteria

* Normal ECG * Regular menstruation

Exclusion criteria

* 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 * Being treated with oral steroids * Has alcohol / drug abuse or is being treated with disulfiram (Antabus) * Is unable to understand the contents of the document with informed consent or the experimental procedures * Pregnancy or breastfeeding * Systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg * ovariectomy * BMI\>28

Design outcomes

Primary

MeasureTime frameDescription
Invasive vascular functionpre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopauseChanges 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
Non-invasive vascular functionpre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopauseChanges 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

Secondary

MeasureTime frameDescription
Changes in skeletal muscle expression of proteinpre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopauseChanges 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.
Changes in skeletal muscle and blood sample expression of RNApre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopauseChanges 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.
Blood pressurepre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopauseChanges in blood pressure across the menopausal transition

Countries

Denmark

Contacts

Primary ContactLasse Gliemann, PhD
gliemann@nexs.ku.dk+4535321632

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 22, 2026