MenopauseNCT05647876
A Longitudinal Study to Identify Mechanisms of Menopause on Cardiovascular Disease Risk
An observational study of Menopause and Cardiovascular Diseases, run by University of Copenhagen at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 61 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Cardiovascular Diseases, Vascular Dilation
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 16 Dec 2022to Aug 2045
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 61 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Normal ECG
- Regular menstruation
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Deparment of Nutrition, Exercise and Sports
Copenhagen, 2100
Lasse Gliemann, PhD
Lasse Gliemann, PhD
About this study
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.
- Medical subject headings
- Cardiovascular Diseases, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause
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
Measured: pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause
Secondary outcomes (3)
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.
Measured: pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause
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.
Measured: pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause
Blood pressure
Changes in blood pressure across the menopausal transition
Measured: pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start16 Dec 2022
- Primary completionDec 2040 (estimated)
- Study completionAug 2045 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lasse Gliemann, University of Copenhagen
- Investigators
- Lasse Gliemann, PhD, Principal investigator, Department of Nutrition, Exercise and Sports, University of Copenhagen, 2200 Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647876
- Sponsor's protocol ID
- KISO STUDY
- Status last verified
- May 2023
- First submitted
- 15 Nov 2022
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Tamariz-Ellemann A, Kleis-Olsen AS, Andersen AB, Thomsen LB, Rocha MP, Frydenholm JF, Jensen JS, Loekkegaard ECL, Hellsten Y, Hybholt M, Gliemann L. Women in healthy transition deep phenotyping cohort study protocol (KiSO-DP): a within-participant multidisciplinary longitudinal cohort study across the menopausal transition. BMJ Open. 2026 Aug 20;16(8):e122003. doi: 10.1136/bmjopen-2026-122003.
PubMed 42624590
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Study to Identify Mechanisms of Menopause on Cardiovascular Disease Risk
- ClinicalTrials.gov ID
- NCT05647876
- Acronym / sponsor ID
- KISO STUDY
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 16 Dec 2022 (actual)
- Primary completion
- Dec 2040 (estimated)
- Study completion
- Aug 2045 (estimated)
- First posted
- 13 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 61 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Normal ECG
- Regular menstruation
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Invasive vascular function
Time frame: pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause
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
Non-invasive vascular function
Time frame: pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause
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
3 secondary outcomes
Changes in skeletal muscle expression of protein
Time frame: pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause
Changes in skeletal muscle and blood sample expression of RNA
Time frame: pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause
Blood pressure
Time frame: pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Derived from this study: PubMed 42624590Tamariz-Ellemann A, Kleis-Olsen AS, Andersen AB, Thomsen LB, Rocha MP, Frydenholm JF, Jensen JS, Loekkegaard ECL, Hellsten Y, Hybholt M, Gliemann L. Women in healthy transition deep phenotyping cohort study protocol (KiSO-DP): a within-participant multidisciplinary longitudinal cohort study across the menopausal transition. BMJ Open. 2026 Aug 20;16(8):e122003. doi: 10.1136/bmjopen-2026-122003.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lasse Gliemann, PhD principal investigator
Department of Nutrition, Exercise and Sports, University of Copenhagen, 2200 Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menopause and Cardiovascular Diseases, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lasse Gliemann, PhD (+4535321632, gliemann@nexs.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Invasive vascular function (time frame: pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05647876, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.