Polycystic Ovary SyndromeNCT01392781
Markers and Calculation of Cardiovascular Risk in the Distinct Phenotypes of Polycystic Ovary Syndrome
An observational study of Polycystic Ovary Syndrome, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
Polycystic ovary syndrome (PCOS) is the most common endocrine disorder and cause of anovulatory infertility among reproductive aged women. According to the revised criteria of 2003, four distinct phenotypes of PCOS can be diagnosed. Read more about this study
- Who is it for?
- Ages 15 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- How many people
- 300 participants
- Where
- 1 siteGreece
- Study dates
- Apr 2011to Jan 2012
- 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 15 to 35 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Outpatient women with PCOS (normalweight, overweight plus obese) Healthy volunteers controls (normalweight, overweight plus obese)
Who may be able to join
- Diagnosis of PCOS (criteria 2003)
- Healthy controls
Who cannot join
- any condition mimicking PCOS
- any systematic disease
Trial locations and contacts
1 site in 1 country.
Georgios Daskalopoulos, M.D. contact
Greece1 site, 1 recruiting
- Recruiting
Second Department of Obstetrics and Gynecology, Third Department of Cardiology, Second Propedeutic Department of Internal Medicine, Aristotle University
Thessaloniki
Vasileios Athyros, Prof
Georgios Daskalopoulos
About this study
Polycystic ovary syndrome (PCOS) is the most common endocrine disorder and cause of anovulatory infertility among reproductive aged women. According to the revised criteria of 2003, four distinct phenotypes of PCOS can be diagnosed. However, there are emerging evidence supporting the existence of different levels of cardiometabolic risk between the four phenotypic groups of the syndrome. The purpose of this study is to determine the cardiovascular risk of i) normoweight and ii)overweight plus obese women of every one of the four phenotypes of the syndrome as well as the levels of low inflammation serum markers and the possible correlations of the between the outcomes.
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- PCOS, hsC-RP, Lp-PLA2, cardiovascular risk
- 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 |
|---|---|---|
| normoweight PCOS patients | Not described | |
| normoweight controls | Not described | |
| overweight plus obese PCOS patients | Not described | |
| overwqeight plus obese controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
high sensitivity C-Reactive Protein (hsC-RP) levels and differences between the phenotypes
Measured: 1 hour
Lipoprotein-associated phospholipase2 (Lp-PLA2) levels and differences between the phenotypes
Measured: 1 hour
Cardiovascular Risk Assessment and differences between the phenotypes
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study startApr 2011
- Primary completionOct 2011 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01392781
- Sponsor's protocol ID
- 14/1-3-2011
- Status last verified
- Jul 2011
- First submitted
- 6 Jul 2011
- Last updated
- 13 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Daskalopoulos G, Karkanaki A, Piouka A, Prapas N, Panidis D, Gkeleris P, Athyros VG. Excess Metabolic and Cardiovascular Risk is not Manifested in all Phenotypes of Polycystic Ovary Syndrome: Implications for Diagnosis and Treatment. Curr Vasc Pharmacol. 2015;13(6):788-800. doi: 10.2174/1567201812666150120163025.
PubMed 25600030
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Markers and Calculation of Cardiovascular Risk in the Distinct Phenotypes of Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT01392781
- Acronym / sponsor ID
- 14/1-3-2011
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- PCOS, hsC-RP, Lp-PLA2, cardiovascular risk
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 13 Jul 2011 (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 the most common endocrine disorder and cause of anovulatory infertility among reproductive aged women. According to the revised criteria of 2003, four distinct phenotypes of PCOS can be diagnosed. However, there are emerging evidence supporting the existence of different levels of cardiometabolic risk between the four phenotypic groups of the syndrome. The purpose of this study is to determine the cardiovascular risk of i) normoweight and ii)overweight plus obese women of every one of the four phenotypes of the syndrome as well as the levels of low inflammation serum markers and the possible correlations of the between the outcomes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| normoweight PCOS patients | – | – |
| normoweight controls | – | – |
| overweight plus obese PCOS patients | – | – |
| overwqeight plus obese controls | – | – |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Outpatient women with PCOS (normalweight, overweight plus obese) Healthy volunteers controls (normalweight, overweight plus obese)
Key inclusion criteria (2 listed)
- Diagnosis of PCOS (criteria 2003)
- Healthy controls
Key exclusion criteria (2 listed)
- any condition mimicking PCOS
- any systematic disease
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
high sensitivity C-Reactive Protein (hsC-RP) levels and differences between the phenotypes
Time frame: 1 hour
Lipoprotein-associated phospholipase2 (Lp-PLA2) levels and differences between the phenotypes
Time frame: 1 hour
Cardiovascular Risk Assessment and differences between the phenotypes
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2011.
- Derived from this study: PubMed 25600030Daskalopoulos G, Karkanaki A, Piouka A, Prapas N, Panidis D, Gkeleris P, Athyros VG. Excess Metabolic and Cardiovascular Risk is not Manifested in all Phenotypes of Polycystic Ovary Syndrome: Implications for Diagnosis and Treatment. Curr Vasc Pharmacol. 2015;13(6):788-800. doi: 10.2174/1567201812666150120163025.
Related trials for Polycystic Ovary Syndrome
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Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
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The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
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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.
Georgios Daskalopoulos, M.D. contact
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 Polycystic Ovary Syndrome, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 2 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: status not confirmed, as of the sponsor's last update on 13 Jul 2011. 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 Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Georgios Daskalopoulos, M.D. (daskalog@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
high sensitivity C-Reactive Protein (hsC-RP) levels and differences between the phenotypes (time frame: 1 hour). The study lists 3 primary outcomes in all. 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 NCT01392781, which also lists 1 linked publication.
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 13 Jul 2011.