NCT05647876 A Longitudinal Study to Identify Mechanisms of Menopause on Cardiovascular Disease Risk
| NCT ID | NCT05647876 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Copenhagen |
| Condition | Menopause |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2022-12-16 |
| Primary Completion | 2040-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2022-12-16 with a primary completion date of 2040-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Lasse Gliemann, PhD
PRINCIPAL INVESTIGATOR
Department of Nutrition, Exercise and Sports, University of Copenhagen, 2200 Copenhagen, Denmark
Frequently Asked Questions
Who can join the NCT05647876 clinical trial?
This trial is open to female participants only, aged 40 Years or older, up to 61 Years, studying Menopause. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05647876 currently recruiting?
Yes, NCT05647876 is actively recruiting participants. Contact the research team at gliemann@nexs.ku.dk for enrollment information.
Where is the NCT05647876 trial being conducted?
This trial is being conducted at Copenhagen, Denmark.
Who is sponsoring the NCT05647876 clinical trial?
NCT05647876 is sponsored by University of Copenhagen. The principal investigator is Lasse Gliemann, PhD at Department of Nutrition, Exercise and Sports, University of Copenhagen, 2200 Copenhagen, Denmark. The trial plans to enroll 200 participants.