Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Recruiting NCT04515303 - Digital Intervention Participation in DASH
Completed NCT04056208 - Pistachios Blood Sugar Control, Heart and Gut Health Phase 2
Recruiting NCT04417387 - The Genetics and Vascular Health Check Study (GENVASC) Aims to Help Determine Whether Gathering Genetic Information Can Improve the Prediction of Risk of Coronary Artery Disease (CAD)
Not yet recruiting NCT06211361 - Cardiac Rehabilitation Program in Patients With Cardiovascular Disease N/A
Not yet recruiting NCT06032572 - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE) N/A
Recruiting NCT04514445 - The BRAVE Study- The Identification of Genetic Variants Associated With Bicuspid Aortic Valve Using a Combination of Case-control and Family-based Approaches.
Enrolling by invitation NCT04253054 - Chinese Multi-provincial Cohort Study-Beijing Project
Completed NCT03273972 - INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers N/A
Completed NCT03680638 - The Effect of Antioxidants on Skin Blood Flow During Local Heating Phase 1
Recruiting NCT04843891 - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis. Phase 1
Completed NCT04083872 - Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of Highdose CKD-385 in Healthy Volunteers(Fasting) Phase 1
Completed NCT04083846 - Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers(Fed) Phase 1
Completed NCT03619148 - The Incidence of Respiratory Symptoms Associated With the Use of HFNO N/A
Completed NCT03693365 - Fluid Responsiveness Tested by the Effective Pulmonary Blood Flow During a Positive End-expiratory Trial
Completed NCT03466333 - Postnatal Enalapril to Improve Cardiovascular fUnction Following Preterm Pre-eclampsia Phase 2
Completed NCT04082585 - Total Health Improvement Program Research Project
Completed NCT05132998 - Impact of a Comprehensive Cardiac Rehabilitation Program Framework Among High Cardiovascular Risk Cancer Survivors N/A
Completed NCT05067114 - Solutions for Atrial Fibrillation Edvocacy (SAFE)