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NCT Number: NCT05647876

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

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.

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Key information

Conditions

Menopause Behavior Cardiovascular Diseases Motor Activity Physical Activity Vascular Dilation

Age range

40 year–61 year

Sex eligibility

Female

Study type

Observational

Primary location

Deparment of Nutrition, Exercise and Sports

Copenhagen, 2100, Denmark

Location status: Recruiting

Location contact

Lasse Gliemann, PhD

CONTACT

Lasse Gliemann, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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 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.

  2. Changes in skeletal muscle and blood sample expression of RNA

    Time frame: pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause

    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.

  3. Blood pressure

    Time frame: pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause

    Changes in blood pressure across the menopausal transition

Study contacts

Contact information is provided by the study sponsor or research team.

Lasse Gliemann, PhD

CONTACT

[email protected]

+4535321632

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Important dates

Study start
2022
Primary completion
2040
Study completion
2045
First posted
Dec 13, 2022
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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