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Completed

NCT Number: NCT01767051

Children Follow-up of PCOS Women

Polycystic ovary syndrome (PCOS) is a complex and frequent disorder with a heterogeneous clinical presentation varying throughout life, from birth up to post-menopause. Although mostly known for its reproductive consequences, PCOS is associated with metabolic abnormalities related to insulin resistance and obesity. Children born from PCOS mothers are considered to be at risk for early insulin resistance, leading to development of PCOS and metabolic abnormalities in childhood and adolescence. Obesity and insulin resistance are considered as states of low- and pro-inflammation associated with endothelial dysfunction. In addition, it has been shown that endothelial dysfunction develops from the first decade of life in response to genetic and environmental risk factors. Therefore, offspring of women with PCOS may be at increased risk for vascular disease later in life. Moreover, some evidence suggests that early life respiratory disease also contributes to later life cardiovascular consequences. The number of studies on offspring of PCOS mothers is low and a systematic follow up of children born form PCOS mothers has not been performed yet. the investigators propose a systematic evaluation of cardiometabolic and pulmonary health characteristics of children (aged 2,5-8 years) born from mothers diagnosed with PCOS. A saliva sample will be performed to determine the biochemical androgenic status of the children. Mothers of these children have undergone standardized phenotyping prior to conception; the investigators will therefore be able to correlate the metabolic status of the mother around the time of conception and the cardiometabolic and pulmonary health of their offspring.

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Key information

Conditions

Cardiovascular Health Metabolic Health Pulmonary Health

Age range

30 month–8 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy Children
  • Children participating in WHISTLER study or children of PCOS mothers
  • Aged 2.5-4 years or 6-8 years

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 are asked to reschedule the appointment.
  • Residency outside the Netherlands
  • Diabetes Mellitus type I
  • Unresolved medical conditions

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.

  6. 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.

Secondary outcomes

  1. 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.

  2. 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)

  3. Flow-volume measurements

    Time frame: 12 months

    Flow-volume measurements will be performed by using spirometry.

  4. Inflammatory markers in exhailed air

    Time frame: 12 months

    Nitric Oxide levels will be measured in exhaled air

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Registry information

Official study title

Children Follow-up of PCOS Women.Cardiovascular Health in Offspring of PCOS Mothers

Acronym: CHOPS

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 11, 2013
Registry last updated
Feb 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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