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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02135575
Other study ID # CWS-WP2CV
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2014
Est. completion date July 2017

Study information

Verified date August 2018
Source University of Copenhagen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The hypothesis of the present study is that physical training can oppose detrimental changes in cardiovascular and metabolic health associated with estrogen loss after menopause.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date July 2017
Est. primary completion date July 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 45 Years to 57 Years
Eligibility Inclusion Criteria:

- Premenopausal (45-53 years) OR postmenopausal 50-57 years

- BMI> 18.5 and <30

- Sedentary (no regular physical activity the last 2 years)

- Plasma measurements

- Premenopausal: estradiol> 0.20 nmol/l, Follicle stimulating hormone < 22 IU/l and progesterone >2.5 nmol/l

- Postmenopausal: estradiol < 0.20 nmol/l, Follicle stimulating hormone > 22 IU/l and progesterone 0.3-2.5 nmol/l

Exclusion Criteria:

- Smoking

- Excessive alcohol intake

- Regular medication including hormone replacement treatment

- Chronic disease

Study Design


Intervention

Behavioral:
Spinning
After the baseline studies the pre and postmenopausal women will be randomized to spinning training groups and the intervention will last for 3 months. The spinning group will spin three times per week under guidance of a trained instructor. The training is heart rate monitored.

Locations

Country Name City State
Denmark University of Copenhagen Copenhagen

Sponsors (3)

Lead Sponsor Collaborator
University of Copenhagen Glostrup University Hospital, Copenhagen, Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other Anthropometry Dual x-ray absorptiometry, height, weight, waist and hip circumference Baseline comparison and changes from baseline to 3 months
Other Activity measure Activity measure for one week by accelerometer Baseline comparison and changes from baseline to 3 months
Primary Leg vascular function Measurements of leg blood flow by ultrasound doppler during exercise and during femoral arterial infusion of vasodilators Baseline comparison and changes from baseline to 3 months
Primary Cardiac structure and function Magnetic resonance imaging and transthoracic echocardiography Baseline comparison and changes from baseline to 3 months
Primary Platelet function Platelet aggregation assay of whole blood and platelet rich plasma Baseline comparison and changes from baseline to 3 months
Secondary Expression of proteins in muscle samples Western Blot analysis of proteins of relevance for vascular function and metabolism Baseline comparison and changes from baseline to 3 months
Secondary Maximal aerobic effect Maximal oxygen uptake during an incremental cycle ergometry test with gas analysis Baseline comparison and changes from baseline to 3 months
Secondary Genomic profile in blood samples Genomic analysis of parameters for vascular and metabolic health Baseline comparison and changes from baseline to 3 months
Secondary Insulin sensitivity and glycaemic control Fasting plasma glucose analysis and oral glucose tolerance test Baseline comparison and changes from baseline to 3 months
Secondary Arterial blood pressure Baseline comparison and changes from baseline to 3 months
Secondary Gene expression of proteins in muscle samples Gene analysis of relevance for vascular and metabolic function Baseline comparison and changes from baseline to 3 months
Secondary Health related parameters in blood Plasma lipid status and other variables related to vascular health Baseline comparison and changes from baseline to 3 months
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