Trial record 9 of 1399 for:    Open Studies | "Health"

Children Follow-up of PCOS Women (CHOPS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by UMC Utrecht
Sponsor:
Information provided by (Responsible Party):
Bart CJM Fauser, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT01767051
First received: January 8, 2013
Last updated: January 10, 2013
Last verified: January 2013
  Purpose

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.


Condition
Cardiovascular Health
Metabolic Health
Pulmonary Health

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Children Follow-up of PCOS Women.Cardiovascular Health in Offspring of PCOS Mothers

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Pulse wave velocity (age 2.5-4 years) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Airway resistance (both age categories) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Flow-volume measurements will be performed by using spirometry.

  • Inflammatory markers in exhailed air [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Nitric Oxide levels will be measured in exhaled air


Biospecimen Retention:   Samples Without DNA

saliva, serum, plasma


Estimated Enrollment: 100
Study Start Date: November 2012
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   30 Months to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Cases Children born from mothers who are diagnosed with PCOS at the UMCU 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.

Controls Children who participated in the WHISTLER study (protocol number 10-194) in . The children were born from mothers with a regular cycle prior to conception and who conceived naturally. The children were examined at the age of 2.5-4 years or at the age of 6-8 years. The data of the WHISTLER 3 and WHISTLER/Cardio study have already been collected.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01767051

Locations
Netherlands
University medical Center Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
Contact: B.C.J.M. Fauser, M.D., PhD    +31887557524    B.C.Fauser@umcutrecht.nl   
Contact: M.A. de Wilde, M.D.    +31887556978    m.wilde-2@umcutrecht.nl   
Principal Investigator: B.C.J.M. Fauser, M.D., PhD         
Sub-Investigator: M.A. de Wilde, M.D.         
Sponsors and Collaborators
UMC Utrecht
  More Information

No publications provided

Responsible Party: Bart CJM Fauser, Professor of Reproductive Medicine, UMC Utrecht
ClinicalTrials.gov Identifier: NCT01767051     History of Changes
Other Study ID Numbers: CHOPS METC 12/308
Study First Received: January 8, 2013
Last Updated: January 10, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:
PCOS
Children
Cardiovascular
Follow-up

ClinicalTrials.gov processed this record on August 27, 2014