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

NCT05647876 | Recruiting DMC

• 1 other identifier: KISO STUDY
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause; Cardiovascular Diseases; Vascular Dilation; Physical Activity

Outcome Measures

Primary Outcomes (2)

• 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

  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

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

Secondary Outcomes (3)

• Changes in skeletal muscle expression of protein

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

• Changes in skeletal muscle and blood sample expression of RNA

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

• Blood pressure

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

Eligibility Criteria

• Age: 40 Years - 61 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Normal ECG
• Regular menstruation

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

Deparment of Nutrition, Exercise and Sports

Copenhagen, 2100, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples, muscle biopsy samples, urine samples

MeSH Terms

Conditions

Cardiovascular Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Lasse Gliemann, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lasse Gliemann, PhD

CONTACT

+4535321632; gliemann@nexs.ku.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: December 13, 2022
• Study Start: December 16, 2022
• Primary Completion (Estimated): December 1, 2040
• Study Completion (Estimated): August 1, 2045
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)