Children follow-up study of PCOS wome
Completed
- Conditions
- PCOSpolycystic ovary syndrome100184241003871610057166
- Registration Number
- NL-OMON39806
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
Cases:
-Children of mothers with PCOS at the age of 2.5-4 years or 5-8 years;Controls:
-Children with the age of 2.5-4 years or 5-8 years
-Mothers of these children must have had a regular cycle and conceived naturally
Exclusion Criteria
-Language barrier
-Children with a history of a heart defect
-Children with a respiratory infection or respiratory infection two weeks previous to the visit (they are asked to reschedule the appointment)
-Residency outside the Netherlands
-Children with Diabetes Mellitus type I
-Children with unresolved medical conditions
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary study parameter/endpoint:<br /><br>To determine cardiovascular health in offspring of PCOS mothers during<br /><br>childhood and to compare it with children from non-PCOS mothers. The main study<br /><br>parameters consist of cardiovascular measurements.<br /><br><br /><br>• Age of 2.5-4 years:<br /><br>Physical examination: anthropometry, blood pressure<br /><br>Cardiovascular parameters: pulse wave velocity, echocardiography (systolic and<br /><br>diastolic function of the right and left ventricle)<br /><br>Sample: saliva sample<br /><br><br /><br>• Age of 5-8 years:<br /><br>Physical examination: anthropometry, blood pressure<br /><br>Cardiovascular parameters: intra-abdominal and subcutaneous fat, carotid intima<br /><br>media thickness (CIMT), vascular stiffness.<br /><br>Samples: serum, saliva sample </p><br>
- Secondary Outcome Measures
Name Time Method <p>To determine pulmonary health in offspring of PCOS mothers during childhood and<br /><br>to compare it with children from non-PCOS mothers:<br /><br><br /><br>• Age of 2.5-4 years:<br /><br>Pulmonary parameters: Interrupter resistance (Rint®)<br /><br><br /><br>• Age of 5-8 years:<br /><br>o Pulmonary parameters: interrupter resistance (Rint®), spirometry,<br /><br>inflammatory markers (nitric oxide) in exhaled air</p><br>