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Clinical Trials/NCT02616510
NCT02616510
Completed
Not Applicable

Primary Ovarian Insufficiency, Polycystic Ovary Syndrome & the CardiOvascular Risk Profile

UMC Utrecht1 site in 1 country125 target enrollmentJuly 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Diseases
Sponsor
UMC Utrecht
Enrollment
125
Locations
1
Primary Endpoint
carotid intima media thickness
Status
Completed
Last Updated
7 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
July 2013
End Date
December 2017
Last Updated
7 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Bart CJM Fauser

professor

UMC Utrecht

Eligibility Criteria

Inclusion Criteria

  • age above 45 years

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

carotid intima media thickness

Time Frame: 10 years post diagnosis

ultrasound measurement of thickness of carotid wall (mean IMT), presence of atherosclerotic plaques (yes/no, location)

Secondary Outcomes

  • insulin and glucose levels(10 years post diagnosis)
  • dyslipidemia(10 years post diagnosis)
  • electrocardiogram (ECG)(10 years post diagnosis)
  • C-reactive protein(10 years post diagnosis)
  • homocysteine(10 years post diagnosis)
  • uric acid(10 years post diagnosis)
  • androgen levels(10 years post diagnosis)
  • cardiac ultrasound (hypertrophy)(10 years post diagnosis)

Study Sites (1)

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