PCOSNCT01463969
High Plasma Level of Long Pentraxin 3 is Associated With Insulin Resistance in Women With Polycystic Ovary Syndrome (PCOS)
An observational study of PCOS, run by Gulhane School of Medicine at 3 sites in Turkey (Türkiye).
Trial summary
In the present study, serum pentraxin 3 level and its relationship with insulin resistance were determined in patients with Polycystic Ovary Syndrome (PCOS. It was found that PTX3 level is increased in patients with PCOS and it is positively correlated with HOMA-IR. 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
- PCOS
- How many people
- 80 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- May 2010to May 2011
- 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: 40 PCOS patients and 40 healty controls
Who may be able to join
- Absence of significant abnormalities on physical examination except hirsutism
- No lipid lowering, hypoglycemic, antihypertensive or hormone replacement therapy
- Normal thyroid function and prolactin level
- Absence of history or evidence of metabolic, cardiovascular, respiratory or hepatic disease
Who cannot join
- Pregnant
- Possible ovarian tumors,
- Congenital adrenal hyperplasia or
- BMI greater than 35 kg/m2
Trial locations and contacts
3 sites in 1 country.
Turkey (Türkiye)3 sites
Gulhane School of Medicine Dep. of Endocrine and Metabolism
Ankara, 06018
Gulhane School of Medicine Dep. of Endocrinology and Metabolism
Ankara, 06018
Gulhane School of Medicine
Ankara, 06018
About this study
Official title: High Plasma Level of Long Pentraxin 3 is Associated With Insulin Resistance in Women With Polycystic Ovary Syndrome
In the present study, serum pentraxin 3 level and its relationship with insulin resistance were determined in patients with Polycystic Ovary Syndrome (PCOS. It was found that PTX3 level is increased in patients with PCOS and it is positively correlated with HOMA-IR.
- Conditions
- PCOS
- Keywords
- PCOS and PTX3 levels
- 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 patients | Not described | |
| Control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of of pentraxin3 in cases with Polycystic Ovarian Syndrome
Mean PTX3 was significantly higher in patients with PCOS. This means that there is increased level of inflamation in patients with PCOS.
Measured: 1 year
Secondary outcomes (1)
Relationship of PTX3 with insuline resistance in patients with PCOS.
PTX3 was positively correlated with HOMA-IR. This means that inflamation may cause insuline resistance in patients with PCOS.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2011 (estimated)
- Study startMay 2010
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOSStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aydogan Aydogdu, Gulhane School of Medicine
- Investigators
- Aydogan Aydogdu, MD, Principal investigator, Gulhane School of Medicine Dep. of Endocrinology and Metabolism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01463969
- Sponsor's protocol ID
- 23.10.2011
- Other IDs
- 24.05.2011
- Status last verified
- Oct 2011
- First submitted
- 23 Oct 2011
- Last updated
- 2 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Plasma Level of Long Pentraxin 3 is Associated With Insulin Resistance in Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT01463969
- Acronym / sponsor ID
- 23.10.2011
- Conditions
- PCOS
- Keywords
- PCOS and PTX3 levels
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- May 2010
- Study completion
- May 2011 (actual)
- First posted
- 2 Nov 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.
In the present study, serum pentraxin 3 level and its relationship with insulin resistance were determined in patients with Polycystic Ovary Syndrome (PCOS. It was found that PTX3 level is increased in patients with PCOS and it is positively correlated with HOMA-IR.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCOS patients | – | – |
| Control group | – | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 40 PCOS patients and 40 healty controls
Key inclusion criteria (4 listed)
- Absence of significant abnormalities on physical examination except hirsutism
- No lipid lowering, hypoglycemic, antihypertensive or hormone replacement therapy
- Normal thyroid function and prolactin level
- Absence of history or evidence of metabolic, cardiovascular, respiratory or hepatic disease
Key exclusion criteria (4 listed)
- Pregnant
- Possible ovarian tumors,
- Congenital adrenal hyperplasia or
- BMI greater than 35 kg/m2
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
Level of of pentraxin3 in cases with Polycystic Ovarian Syndrome
Time frame: 1 year
Mean PTX3 was significantly higher in patients with PCOS. This means that there is increased level of inflamation in patients with PCOS.
1 secondary outcome
Relationship of PTX3 with insuline resistance in patients with PCOS.
Time frame: 1 year
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 2 Nov 2011.
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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.
Aydogan Aydogdu, MD principal investigator
Gulhane School of Medicine Dep. of Endocrinology and Metabolism
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PCOS, run by Gulhane School of Medicine at 3 sites in Turkey (Türkiye).
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 4 inclusion and 4 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 2 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Turkey (Türkiye). 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?
Level of of pentraxin3 in cases with Polycystic Ovarian Syndrome (time frame: 1 year). 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 2 Nov 2011.