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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05647876
Other study ID # KISO STUDY
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 16, 2022
Est. completion date August 2045

Study information

Verified date May 2023
Source University of Copenhagen
Contact Lasse Gliemann, PhD
Phone +4535321632
Email gliemann@nexs.ku.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date August 2045
Est. primary completion date December 2040
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 40 Years to 61 Years
Eligibility 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

Study Design


Locations

Country Name City State
Denmark Deparment of Nutrition, Exercise and Sports Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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.
pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause
Secondary 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.
pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause
Secondary Blood pressure Changes in blood pressure across the menopausal transition pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause
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