Clinical trial NCT05647876: A Longitudinal Study to Identify Mechanisms of Menopause on Cardiovascular Disease Risk
Official title: A Longitudinal Study to Identify Mechanisms of Menopause on Cardiovascular Disease Risk
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Menopause
Cardiovascular Diseases
Vascular Dilation
Physical Activity
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2022-12-13
Enrollment: 200
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 61
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Invasive vascular function
timeFrame: pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause
measure: Non-invasive vascular function
timeFrame: pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause
Secondary outcomes:
measure: Changes in skeletal muscle expression of protein
timeFrame: pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause
measure: Changes in skeletal muscle and blood sample expression of RNA
timeFrame: pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause
measure: Blood pressure
timeFrame: pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Deparment of Nutrition, Exercise and Sports
Study officials:
affiliation: Department of Nutrition, Exercise and Sports, University of Copenhagen, 2200 Copenhagen, Denmark
name: Lasse Gliemann, PhD
role: PRINCIPAL_INVESTIGATOR
References: