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

NCT ID: NCT05647876

Last Updated: 2023-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-16

Study Completion Date

2045-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Menopause Cardiovascular Diseases Vascular Dilation Physical Activity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

61 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Lasse Gliemann

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lasse Gliemann, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Nutrition, Exercise and Sports, University of Copenhagen, 2200 Copenhagen, Denmark

Locations

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Deparment of Nutrition, Exercise and Sports

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Lasse Gliemann, PhD

Role: CONTACT

+4535321632

Facility Contacts

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Lasse Gliemann, PhD

Role: primary

Other Identifiers

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KISO STUDY

Identifier Type: -

Identifier Source: org_study_id

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