Clinical trial NCT01767051: Children Follow-up of PCOS Women
Official title: Children Follow-up of PCOS Women.Cardiovascular Health in Offspring of PCOS Mothers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Health
Metabolic Health
Pulmonary Health
Keywords: PCOS
Children
Cardiovascular
Follow-up
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2013-01-11
Enrollment: 74
Sex: ALL
Minimum age (years): 30
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility 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

Primary outcomes:
measure: Pulse wave velocity (age 2.5-4 years)
timeFrame: 12 months
measure: Echocardiography (age 2.5-4 years)
timeFrame: 12 months
measure: Anthropometry (both age categories)
timeFrame: 12 months
measure: Carotid intima media thickness (age 6-8 years)
timeFrame: 12 months
measure: Fat mass determination (6-8 years)
timeFrame: 12 months
measure: Blood sample (6-8 years)
timeFrame: 12 months
Secondary outcomes:
measure: Airway resistance (both age categories)
timeFrame: 12 months
measure: Saliva sample (both age categories)
timeFrame: 12 months
measure: Flow-volume measurements
timeFrame: 12 months
measure: Inflammatory markers in exhailed air
timeFrame: 12 months
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University medical Center Utrecht
Study officials:
References: