Polycystic Ovary SyndromeNCT01088061
Adipose Expression of Leptin, Adiponectin and IL-6 and Plasma Levels of Adipocytokines in Women With and Without Polycystic Ovary Syndrome (PCOS)
An observational study of Polycystic Ovary Syndrome, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
Trial summary
The purpose of the study was to investigate adipose expression and plasma levels of different adipocytokine, which may play a role in the pathophysiology of PCOS. The investigators investigated lean and obese 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
- 65 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2004to Apr 2006
- 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: Lean and obese women with and without PCOS, age 18-40 years.
Who may be able to join
- women with PCOS according to the Rotterdam criteria
Who cannot join
- other known diseases
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Copenhagen University Hospital, Hvidovre
Hvidovre, Denmark, 1650
About this study
Official title: Adipocytokines in Lean and Obese Women With and Without PCOS
The purpose of the study was to investigate adipose expression and plasma levels of different adipocytokine, which may play a role in the pathophysiology of PCOS. The investigators investigated lean and obese women with and without PCOS.
- Conditions
- Polycystic Ovary Syndrome
- 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 |
|---|---|---|
| lean women with PCOS | Not described | |
| Obese women with PCOS | Not described | |
| lean control women | Not described | |
| Obese control women | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adipose expression of adipocytokines
Measured: From February 2004 -April 2006
Secondary outcomes (1)
Plasma levels of adipocytokines
Measured: From February 2004-April 2006
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2010 (estimated)
- Study startJan 2004
- Primary completionApr 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Statens Serum Institut
- Investigators
- Pernille Fog Svendsen, MD, Principal investigator, Copenhagen University Hospital, Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01088061
- Sponsor's protocol ID
- pcos0509
- Status last verified
- Jan 2008
- First submitted
- 16 Mar 2010
- Last updated
- 28 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adipocytokines in Lean and Obese Women With and Without PCOS
- ClinicalTrials.gov ID
- NCT01088061
- Acronym / sponsor ID
- pcos0509
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Statens Serum Institut
- Study start
- Jan 2004
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 17 Mar 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.
The purpose of the study was to investigate adipose expression and plasma levels of different adipocytokine, which may play a role in the pathophysiology of PCOS. The investigators investigated lean and obese women with and without PCOS.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| lean women with PCOS | – | – |
| Obese women with PCOS | – | – |
| lean control women | – | – |
| Obese control women | – | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Lean and obese women with and without PCOS, age 18-40 years.
Key inclusion criteria (1 listed)
- women with PCOS according to the Rotterdam criteria
Key exclusion criteria (1 listed)
- other known 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
Adipose expression of adipocytokines
Time frame: From February 2004 -April 2006
1 secondary outcome
Plasma levels of adipocytokines
Time frame: From February 2004-April 2006
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 28 Oct 2011.
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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The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
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Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
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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.
Pernille Fog Svendsen, MD principal investigator
Copenhagen University Hospital, Hvidovre
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 Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
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 1 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 28 Oct 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 Denmark. 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?
Adipose expression of adipocytokines (time frame: From February 2004 -April 2006). 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 28 Oct 2011.