Children Follow-up of PCOS Women (CHOPS)
|ClinicalTrials.gov Identifier: NCT01767051|
Recruitment Status : Completed
First Posted : January 11, 2013
Last Update Posted : February 20, 2015
|Condition or disease|
|Cardiovascular Health Metabolic Health Pulmonary Health|
|Study Type :||Observational|
|Actual Enrollment :||74 participants|
|Observational Model:||Case Control|
|Official Title:||Children Follow-up of PCOS Women.Cardiovascular Health in Offspring of PCOS Mothers|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Children born from mothers who are diagnosed with PCOS
Children at the age of 2.5-4 years or at the age of 6-8 years born from mothers who are diagnosed with PCOS at the University Medical Centre in Utrecht (UMCU) in the period 2004-2012 (n=891) will be asked to participate. Children who were born before the diagnosed PCOS of their mothers at the UMCU will be asked to participate too. All mothers have been diagnosed with PCOS according to standardised extensive diagnostic work-up and have given informed consent to be approached for future research purposes.
Children who participated in the WHISTLER study
Children who participated in the WHISTLER 3 (11-163) and WHISTLER/Cardio study (10-194) in 2002-2012. The children were born from mothers with a regular cycle prior to conception who conceived naturally. The children were examined at the age of 2.5-4 years or at the age of 7-8 years. The data of the WHISTLER 3 and WHISTLER/Cardio study have already been collected.
- Pulse wave velocity (age 2.5-4 years) [ Time Frame: 12 months ]The pulse wave velocity will be measured twice using the Arteriograph at the right arm. This measurement will start by performing a blood pressure measurement at the first phase. In the second phase the pulse wave recording for pulse waveform analysis is performed. First the device will inflate back to the measured diastolic value and register the pulse waves and second, the device inflates further to the suprasystolic value (to the measured systolic value +35 mmHg), occluding the brachial artery completely in this way and registers the pulse waves.
- Echocardiography (age 2.5-4 years) [ Time Frame: 12 months ]Echocardiography will be performed in a supine position. Three ECG electrodes will be attached on the skin. The child can watch a movie during the measurements. Using M-mode and Tissue Doppler Echocardiography several measurements of the systolic and diastolic function of the right and left ventricle will be performed.
- Anthropometry (both age categories) [ Time Frame: 12 months ]Body height and weight will be measured to the nearest 0.1 cm and 0.1 kg respectively without wearing shoes. Distance between the jugular fossa and symphysis will be measured (needed for calculation of pulse wave velocity). Waist circumference will be measured twice at the bare skin using a non-elastic measuring tape, between the superior iliac anterior spine and the lowest rib in a horizontal line, at the end of a normal expiration. Hip circumference will be measured twice over light clothing at the most posterior point of the buttocks. Thoracic circumference will be measured at the end of the expiration and signs of respiratory disease will be noted.
- Carotid intima media thickness (age 6-8 years) [ Time Frame: 12 months ]The carotid IMT will be determined by using ultrasound based on the gold standard Wall Track System (Art.lab System, Esaote and the Cardiovascular Research Institute Maastricht).
- Fat mass determination (6-8 years) [ Time Frame: 12 months ]The intra-abdominal fat will be assessed by ultrasound by determination of the distance between the posterior side of the linea alba and the anterior vertebrae. The subcutaneous fat will be determined by measuring the distance between the anterior side of the linea alba and the skin. Both fat compartments will be assessed longitudinally.
- Blood sample (6-8 years) [ Time Frame: 12 months ]The venous puncture will be performed for the collection of the blood sample by using a butterfly needle, since this needle is smaller than the needles commonly used for venous puncture (vacutainer system) and will therefore reduce the pain of the venous puncture for the children. The venipuncture will be performed in a vein in the cubital fossa. Two different tubes of blood will be drawn, one sodium-heparin and one lithium-heparin tube, with in total a maximum of 19 cc blood. Prior to the venous puncture, a local anaesthetic, xylocaine spray, will be used at the location of the puncture.
- Airway resistance (both age categories) [ Time Frame: 12 months ]Measurements of the airway resistance will be measured with the MicroRint using the interrupter technique according to standardized criteria. The child breathes passively through a mouthpiece. A rapidly occluding valve automatically interrupts the airflow for a period so brief as to be imperceptible to the patient. The airway resistance will automatically be computed.
- Saliva sample (both age categories) [ Time Frame: 12 months ]Saliva will be collected unstimulated by spittinh in a paper cup or with a Salimetrics children's swab. The saliva will be stored in a freezer (-80 degrees)
- Flow-volume measurements [ Time Frame: 12 months ]Flow-volume measurements will be performed by using spirometry.
- Inflammatory markers in exhailed air [ Time Frame: 12 months ]Nitric Oxide levels will be measured in exhaled air
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01767051
|University medical Center Utrecht|
|Utrecht, Netherlands, 3584 CX|