Actively Recruiting
A Longitudinal Study to Identify Mechanisms of Menopause on Cardiovascular Disease Risk
Led by University of Copenhagen · Updated on 2023-05-10
200
Participants Needed
1
Research Sites
243 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to understand how menopause affects the risk of cardiovascular diseases such as atherosclerosis, heart attacks, and strokes in women. It focuses on the time around menopause when estrogen production stops, which is linked to a higher risk of these conditions. The study will follow 200 women from before menopause to at least 10 years after, using advanced methods to observe changes in blood vessels, the heart, and the brain, along with microRNA analysis of blood and tissue samples. Participants will be observed over a long period with repeated assessments before menopause and at 1, 3, 5, 10, and 20 years after menopause. These assessments include invasive and non-invasive measures of vascular function, as well as monitoring changes in skeletal muscle proteins and RNA expression from muscle and blood samples. Blood pressure will also be tracked regularly during this time. Women involved in the study will undergo detailed cardiovascular and biological evaluations at various time points throughout the study. This includes tests of blood vessel function, muscle tissue analysis, and blood sample collections. The researchers will also monitor blood pressure and other health indicators to understand the long-term impact of menopause on cardiovascular health. The total participation may last over 20 years, providing extensive data on how menopause influences disease risk over time.
CONDITIONS
Brief Title
A Longitudinal Study to Identify Mechanisms of Menopause on Cardiovascular Disease Risk
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Normal ECG
- Regular menstruation
- Female aged between 40 and 61 years
You will not qualify if you...
- Participation in other clinical projects
- Smokes or has smoked within the last 10 years
- On hormone therapy
- Has chronic diseases not expected, including heart problems, atrial fibrillation, cancer, immune diseases, or previous strokes with significant effects
- Being treated with oral steroids
- Has alcohol or drug abuse or is treated with disulfiram (Antabus)
- Unable to understand informed consent or study procedures
- Pregnancy or breastfeeding
- Systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg
- Ovariectomy
- BMI greater than 28
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 20 years post menopause
Participants undergo assessments of vascular function, skeletal muscle, RNA expression, and blood pressure before and at multiple timepoints after menopause.
Visits at pre-menopause and 1, 3, 5, 10, and 20 years post menopause
Trial Site Locations
Total: 1 location
1
Deparment of Nutrition, Exercise and Sports
Copenhagen, Denmark, 2100
Actively Recruiting
Research Team
L
Lasse Gliemann, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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