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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02616510
Other study ID # 13-010
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 2013
Est. completion date December 2017

Study information

Verified date December 2018
Source UMC Utrecht
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The polycystic ovary syndrome (PCOS) is the most common endocrinopathy amongst women of reproductive age. PCOS is associated with various cardiovascular risk factors such as obesity, glucose intolerance, dyslipidemia hypertension and the metabolic syndrome. Whether these increased cardiovascular risk factors result in the development of actual cardiovascular disease in later life remains to be established.

Women with premature ovarian insufficiency (POI), experience menopause prior to the age of 40 years. Women with POI may exhibit dyslipidemia. A young age at menopause has been previously associated with increased cardiovascular morbidity and mortality.


Description:

Cardiovascular risk profile will be assessed in women with PCOS and POI > 45 years of age, consisting of:

fasting serum and urine analyses blood pressure, length, weight, waist circumference, hip circumference ECG carotid intima media thickness cardiac ultrasound

spare serum, plasma and urine will be stored in -80 degrees celsius biobank.


Recruitment information / eligibility

Status Completed
Enrollment 125
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Female
Age group 45 Years and older
Eligibility Inclusion Criteria:

- age above 45 years

Exclusion Criteria:

Study Design


Intervention

Procedure:
cardiovascular screening
cardiovascular screening: serum, urine, ECG, carotid intima media thickness (IMT), cardiac ultrasound

Locations

Country Name City State
Netherlands University Medical Center Utrecht Utrecht

Sponsors (3)

Lead Sponsor Collaborator
UMC Utrecht Erasmus Medical Center, VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary carotid intima media thickness ultrasound measurement of thickness of carotid wall (mean IMT), presence of atherosclerotic plaques (yes/no, location) 10 years post diagnosis
Secondary dyslipidemia serum measurement of low density lipoprotein cholesterol, triglycerides, total cholesterol, high density lipoprotein cholesterol 10 years post diagnosis
Secondary insulin and glucose levels 10 years post diagnosis
Secondary C-reactive protein 10 years post diagnosis
Secondary homocysteine 10 years post diagnosis
Secondary uric acid 10 years post diagnosis
Secondary androgen levels 10 years post diagnosis
Secondary electrocardiogram (ECG) documentation of heart rythm, potential signs of ischemia (ST segment), length PR, QRS, QT, RR interval 10 years post diagnosis
Secondary cardiac ultrasound (hypertrophy) measurement of left ventricular ejection fraction and left ventricular mass, 10 years post diagnosis
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