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

Sponsor
University of Copenhagen (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05647876
Collaborator
(none)
200
Enrollment
1
Location
272
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Longitudinal Study to Identify Mechanisms of Menopause on Cardiovascular Disease Risk
    Anticipated Study Start Date :
    Dec 1, 2022
    Anticipated Primary Completion Date :
    Dec 1, 2040
    Anticipated Study Completion Date :
    Aug 1, 2045

    Outcome Measures

    Primary Outcome Measures

    1. Invasive vascular function [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 [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 Outcome Measures

    1. Changes in skeletal muscle expression of protein [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 [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 [pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause]

      Changes in blood pressure across the menopausal transition

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 61 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Deparment of Nutrition, Exercise and Sports Copenhagen Denmark 2100

    Sponsors and Collaborators

    • University of Copenhagen

    Investigators

    • Principal Investigator: Lasse Gliemann, PhD, Department of Nutrition, Exercise and Sports, University of Copenhagen, 2200 Copenhagen, Denmark

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lasse Gliemann, Associate Professor, University of Copenhagen
    ClinicalTrials.gov Identifier:
    NCT05647876
    Other Study ID Numbers:
    • KISO STUDY
    First Posted:
    Dec 13, 2022
    Last Update Posted:
    Dec 13, 2022
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Cardiovascular Diseases

    Study Results

    No Results Posted as of Dec 13, 2022