Children Follow-up of PCOS Women

NCT ID: NCT01767051

Last Updated: 2015-02-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 74 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2014-12-31

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.

Conditions

Pulmonary Health; Cardiovascular Health; Metabolic Health

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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

• Minimum Eligible Age: 30 Months
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

UMC Utrecht

OTHER

Sponsor Role: lead

Responsible Party

Bart CJM Fauser

Professor of Reproductive Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University medical Center Utrecht

Utrecht, Utrecht, Netherlands

Countries

Netherlands

Other Identifiers

CHOPS METC 12/308

Identifier Type: -

Identifier Source: org_study_id