Cardiovascular HealthCHOPSNCT01767051
Children Follow-up of PCOS Women
An observational study of Cardiovascular Health and Metabolic Health, run by UMC Utrecht at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 30 months to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Health, Metabolic Health, Pulmonary Health
- How many people
- 74 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2012to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 months to 8 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Healthy Children
- Children participating in WHISTLER study or children of PCOS mothers
- Aged 2.5-4 years or 6-8 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University medical Center Utrecht
Utrecht, Utrecht, 3584 CX
About this study
Official title: Children Follow-up of PCOS Women.Cardiovascular Health in Offspring of PCOS Mothers
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
- Cardiovascular Health, Metabolic Health, Pulmonary Health
- Keywords
- PCOS, Children, Cardiovascular, Follow-up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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).
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
Secondary outcomes (4)
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.
Measured: 12 months
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)
Measured: 12 months
Flow-volume measurements
Flow-volume measurements will be performed by using spirometry.
Measured: 12 months
Inflammatory markers in exhailed air
Nitric Oxide levels will be measured in exhaled air
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study startNov 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular HealthStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bart CJM Fauser, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01767051
- Sponsor's protocol ID
- CHOPS METC 12/308
- Acronym
- CHOPS
- Status last verified
- Feb 2015
- First submitted
- 8 Jan 2013
- Last updated
- 20 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children Follow-up of PCOS Women.Cardiovascular Health in Offspring of PCOS Mothers
- ClinicalTrials.gov ID
- NCT01767051
- Acronym / sponsor ID
- CHOPS / CHOPS METC 12/308
- Conditions
- Cardiovascular Health, Metabolic Health, Pulmonary Health
- Keywords
- PCOS, Children, Cardiovascular, Follow-up
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 30 months to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- Healthy Children
- Children participating in WHISTLER study or children of PCOS mothers
- Aged 2.5-4 years or 6-8 years
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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).
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.
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.
4 secondary outcomes
Airway resistance (both age categories)
Time frame: 12 months
Saliva sample (both age categories)
Time frame: 12 months
Flow-volume measurements
Time frame: 12 months
Inflammatory markers in exhailed air
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Health and Metabolic Health, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse wave velocity (age 2.5-4 years) (time frame: 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2015.