Children Follow-up of PCOS Women

Cardiovascular Health Clinical Trial

— CHOPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01767051
• Other study ID #: CHOPS METC 12/308
• Status: Completed
• Phase: N/A
• First received: January 8, 2013
• Last updated: February 19, 2015
• Start date: November 2012
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Months to 8 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Health
• Metabolic Health
• Pulmonary Health

Locations

Country	Name	City	State
Netherlands	University medical Center Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulse wave velocity (age 2.5-4 years)	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.	12 months	No
Primary	Echocardiography (age 2.5-4 years)	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.	12 months	No
Primary	Anthropometry (both age categories)	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.	12 months	No
Primary	Carotid intima media thickness (age 6-8 years)	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).	12 months	No
Primary	Fat mass determination (6-8 years)	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.	12 months	No
Primary	Blood sample (6-8 years)	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.	12 months	No
Secondary	Airway resistance (both age categories)	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.	12 months	No
Secondary	Saliva sample (both age categories)	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)	12 months	Yes
Secondary	Flow-volume measurements	Flow-volume measurements will be performed by using spirometry.	12 months	No
Secondary	Inflammatory markers in exhailed air	Nitric Oxide levels will be measured in exhaled air	12 months	No