Polycystic Ovary SyndromeCSNCT01195168
Cardiovascular Risk Markers in Polycystic Ovary Syndrome (PCOS)
An observational study of Polycystic Ovary Syndrome, run by The Adelaide and Meath Hospital at 2 sites in Ireland.
Trial summary
Women with polycystic ovary syndrome (PCOS) are more often overweight or obese and are more insulin resistant than women without the condition and may be at greater risk of developing cardiovascular disease. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- How many people
- 201 participants
- Where
- 2 sitesIreland
- Study dates
- Nov 2006to Jul 2008
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women with PCOS and a control population of women matched for age and body mass index (BMI) and insulin resistance
Who may be able to join
- Had a positive diagnosis of PCOS as defined according to the NIH criteria as chronic oligomenorrhoea (< 9 menstrual cycles per year) and clinical and/or biochemical evidence of hyperandrogenism, in the absence of other disorders causing the same phenotype. Clinical criteria included hirsutism with a Ferriman-Galwey score greater than 9, acne or male pattern alopecia; biochemical criteria included total-testosterone, androstenedione or dehydroepiandrosterone sulphate (DHEAS) greater than the laboratory reference range.
- Were between the ages of 18 and 40
Who cannot join
- Were under 18 years or greater than 40 years old,
- Were non-Caucasian
- Were pregnant, lactating or trying to conceive
- Had a body mass index (BMI) <18kg/m2 or >50kg/m2
- Had a recent illness or any chronic illness likely to influence results
- Were taking hormonal contraception
Trial locations and contacts
2 sites in 1 country.
Ireland2 sites
Diabetes Day Centre, The Adelaide and Meath Hosptial
Dublin, Leinster, Dublin 24
Nutrigenomics Research Group, University College Dublin
Dublin, Leinster, Dublin 4
About this study
Official title: Assessment of Cardiovascular Risk in PCOS-a Cross Sectional Study of Women With PCOS Compared With Controls Matched for Age, Body Mass Index and, or Insulin Resistance
Women with polycystic ovary syndrome (PCOS) are more often overweight or obese and are more insulin resistant than women without the condition and may be at greater risk of developing cardiovascular disease. It is not know whether it is the overweight and insulin resistant component of PCOS, or PCOS per se which leads to the greater cardiovascular disease risk. The aim of this study was to examine cardiovascular risk markers in women with PCOS versus a control population matched for body mass index (BMI), and or, insulin resistance
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- PCOS
- Medical subject headings
- Polycystic Ovary Syndrome
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 |
|---|---|---|
| PCOS cohort | Women with PCOS as diagnosed by the NIH criteria | |
| Control cohort | Women without PCOS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Insulin resistance in women with PCOS compared with BMI and age matched controls
Subjects underwent a standard 75g oral glucose tolerance test (OGTT) and blood were taken fasting and at 2 hours. Surrogate markers of insulin resistance (HOMA) and insulin sensitivity (Avignon index of Insulin Sensitivity; QUICKI) were calculated
Measured: Recruitment ran from Nov 2006-July 2008; Each subject attended the study location fasting on one occasion
Secondary outcomes (3)
Assessment of concentrations of androgens in women with PCOS compared with controls
Bloods were taken in the fasted state and circulating concentrations of androgens (DHEAS, testosterone, androstenedione) were assessed
Measured: Recruitment ran from Nov 2006-July 2008; Each subject attended the study location fasting on one occasion
Assessment of lipid profile in women with PCOS compared with age matched controls
Bloods were taken in the fasted state and circulating concentrations of lipids assessed
Measured: Recruitment ran from Nov 2006-July 2008; Each subject attended the study location fasting on one occasion
Assessment of inflammatory profile in women with PCOS compared with controls
Bloods were taken in the fasted state and circulating concetrations of several important markers of inflammation as well as key adipokines were assessed
Measured: Recruitment ran from Nov 2006-July 2008; Each subject attended the study location fasting on one occasion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2010 (estimated)
- Study startNov 2006
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Adelaide and Meath Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University College Dublin
- Investigators
- James Gibney, Dr, Principal investigator, The Adelaide and Meath HospitalHelen M Roche, Prof, Principal investigator, University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01195168
- Sponsor's protocol ID
- DDC-UCD-CS
- Acronym
- CS
- Status last verified
- Jul 2008
- First submitted
- 2 Sep 2010
- Last updated
- 6 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Gidwani S, Phelan N, McGill J, McGowan A, O'Connor A, Young IS, Gibney J, McEneny J. Polycystic ovary syndrome influences the level of serum amyloid A and activity of phospholipid transfer protein in HDL(2) and HDL(3). Hum Reprod. 2014 Jul;29(7):1518-25. doi: 10.1093/humrep/deu115. Epub 2014 May 19.
PubMed 24842896Phelan N, O'Connor A, Kyaw Tun T, Correia N, Boran G, Roche HM, Gibney J. Hormonal and metabolic effects of polyunsaturated fatty acids in young women with polycystic ovary syndrome: results from a cross-sectional analysis and a randomized, placebo-controlled, crossover trial. Am J Clin Nutr. 2011 Mar;93(3):652-62. doi: 10.3945/ajcn.110.005538. Epub 2011 Jan 26.
PubMed 21270384
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cardiovascular Risk in PCOS-a Cross Sectional Study of Women With PCOS Compared With Controls Matched for Age, Body Mass Index and, or Insulin Resistance
- ClinicalTrials.gov ID
- NCT01195168
- Acronym / sponsor ID
- CS / DDC-UCD-CS
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- PCOS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- The Adelaide and Meath HospitalUniversity, hospital or other
- Collaborators
- University College Dublin
- Study start
- Nov 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 6 Sep 2010 (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.
Women with polycystic ovary syndrome (PCOS) are more often overweight or obese and are more insulin resistant than women without the condition and may be at greater risk of developing cardiovascular disease. It is not know whether it is the overweight and insulin resistant component of PCOS, or PCOS per se which leads to the greater cardiovascular disease risk. The aim of this study was to examine cardiovascular risk markers in women with PCOS versus a control population matched for body mass index (BMI), and or, insulin resistance
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCOS cohort | – | –Women with PCOS as diagnosed by the NIH criteria |
| Control cohort | – | –Women without PCOS |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women with PCOS and a control population of women matched for age and body mass index (BMI) and insulin resistance
Key inclusion criteria (2 listed)
- Had a positive diagnosis of PCOS as defined according to the NIH criteria as chronic oligomenorrhoea (< 9 menstrual cycles per year) and clinical and/or biochemical evidence of hyperandrogenism, in the absence of other disorders causing the same phenotype. Clinical criteria included hirsutism with a Ferriman-Galwey score greater than 9, acne or male pattern alopecia; biochemical criteria included total-testosterone, androstenedione or dehydroepiandrosterone sulphate (DHEAS) greater than the laboratory reference range.
- Were between the ages of 18 and 40
Key exclusion criteria (6 listed)
- Were under 18 years or greater than 40 years old,
- Were non-Caucasian
- Were pregnant, lactating or trying to conceive
- Had a body mass index (BMI) <18kg/m2 or >50kg/m2
- Had a recent illness or any chronic illness likely to influence results
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
Assessment of Insulin resistance in women with PCOS compared with BMI and age matched controls
Time frame: Recruitment ran from Nov 2006-July 2008; Each subject attended the study location fasting on one occasion
Subjects underwent a standard 75g oral glucose tolerance test (OGTT) and blood were taken fasting and at 2 hours. Surrogate markers of insulin resistance (HOMA) and insulin sensitivity (Avignon index of Insulin Sensitivity; QUICKI) were calculated
3 secondary outcomes
Assessment of concentrations of androgens in women with PCOS compared with controls
Time frame: Recruitment ran from Nov 2006-July 2008; Each subject attended the study location fasting on one occasion
Assessment of lipid profile in women with PCOS compared with age matched controls
Time frame: Recruitment ran from Nov 2006-July 2008; Each subject attended the study location fasting on one occasion
Assessment of inflammatory profile in women with PCOS compared with controls
Time frame: Recruitment ran from Nov 2006-July 2008; Each subject attended the study location fasting on one occasion
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 6 Sep 2010.
- Derived from this study: PubMed 24842896Gidwani S, Phelan N, McGill J, McGowan A, O'Connor A, Young IS, Gibney J, McEneny J. Polycystic ovary syndrome influences the level of serum amyloid A and activity of phospholipid transfer protein in HDL(2) and HDL(3). Hum Reprod. 2014 Jul;29(7):1518-25. doi: 10.1093/humrep/deu115. Epub 2014 May 19.
- Derived from this study: PubMed 21270384Phelan N, O'Connor A, Kyaw Tun T, Correia N, Boran G, Roche HM, Gibney J. Hormonal and metabolic effects of polyunsaturated fatty acids in young women with polycystic ovary syndrome: results from a cross-sectional analysis and a randomized, placebo-controlled, crossover trial. Am J Clin Nutr. 2011 Mar;93(3):652-62. doi: 10.3945/ajcn.110.005538. Epub 2011 Jan 26.
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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.
James Gibney, Dr principal investigator
The Adelaide and Meath Hospital
Helen M Roche, Prof principal investigator
University College Dublin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome, run by The Adelaide and Meath Hospital at 2 sites in Ireland.
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 2 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 6 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland. 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?
Assessment of Insulin resistance in women with PCOS compared with BMI and age matched controls (time frame: Recruitment ran from Nov 2006-July 2008; Each subject attended the study location fasting on one occasion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01195168, which also lists 2 linked publications.
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 6 Sep 2010.