Polycystic Ovary SyndromeNCT00975832
Adipocytokines and Polycystic Ovary Syndrome (PCOS)
An observational study of Polycystic Ovary Syndrome, run by Hvidovre University Hospital.
Trial summary
Inflammation may play a role in the development of polycystic ovary syndrome (PCOS). In this study, the investigators investigated the expression of different mediators of inflammation in fatty tissue and in blood in women with and without PCOS. 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
- 60 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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: 36 women (17 lean and 19 obese)with PCOS and 24 (8 lean and 16 obese) control women
Who may be able to join
- Women with PCOS were included according to the Rotterdam diagnostic criteria for PCOS. Control women met none of the criteria for PCOS
Who cannot join
- Oc´s within the last three months, or other medication known to alter glucose/insulin metabolism
- Other known chronic diseases
About this study
Official title: Adipose Expression of Leptin, Adiponectin and IL-6, and Plasma Levels of Adipocytokines in Lean and Obese Women With PCOS
Inflammation may play a role in the development of polycystic ovary syndrome (PCOS). In this study, the investigators investigated the expression of different mediators of inflammation in fatty tissue and in blood in women with and without PCOS.
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- The independent effect of PCOS and obesity on adipose expression and plasma levels of adipocytokines
- 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 |
|---|---|---|
| women with polycystic ovary syndrome | Not described | |
| women without polycystic ovary syndrome | Not described | |
| women from 18-40 years of age | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2009 (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.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Statens Serum Institut, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00975832
- Sponsor's protocol ID
- PSvendsen
- Status last verified
- Sep 2009
- First submitted
- 10 Sep 2009
- Last updated
- 11 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Svendsen PF, Christiansen M, Hedley PL, Nilas L, Pedersen SB, Madsbad S. Adipose expression of adipocytokines in women with polycystic ovary syndrome. Fertil Steril. 2012 Jul;98(1):235-41. doi: 10.1016/j.fertnstert.2012.03.056. Epub 2012 May 16.
PubMed 22607892
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adipose Expression of Leptin, Adiponectin and IL-6, and Plasma Levels of Adipocytokines in Lean and Obese Women With PCOS
- ClinicalTrials.gov ID
- NCT00975832
- Acronym / sponsor ID
- PSvendsen
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- The independent effect of PCOS and obesity on adipose expression and plasma levels of adipocytokines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Statens Serum Institut, Aarhus University Hospital
- First posted
- 11 Sep 2009 (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.
Inflammation may play a role in the development of polycystic ovary syndrome (PCOS). In this study, the investigators investigated the expression of different mediators of inflammation in fatty tissue and in blood in women with and without PCOS.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| women with polycystic ovary syndrome | – | – |
| women without polycystic ovary syndrome | – | – |
| women from 18-40 years of age | – | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 36 women (17 lean and 19 obese)with PCOS and 24 (8 lean and 16 obese) control women
Key inclusion criteria (1 listed)
- Women with PCOS were included according to the Rotterdam diagnostic criteria for PCOS. Control women met none of the criteria for PCOS
Key exclusion criteria (2 listed)
- Oc´s within the last three months, or other medication known to alter glucose/insulin metabolism
- Other known chronic diseases
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
Not reported in the source record.
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 11 Sep 2009.
- Derived from this study: PubMed 22607892Svendsen PF, Christiansen M, Hedley PL, Nilas L, Pedersen SB, Madsbad S. Adipose expression of adipocytokines in women with polycystic ovary syndrome. Fertil Steril. 2012 Jul;98(1):235-41. doi: 10.1016/j.fertnstert.2012.03.056. Epub 2012 May 16.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome, run by Hvidovre University Hospital.
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 1 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: finished, as of the sponsor's last update on 11 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00975832, 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 11 Sep 2009.