Polycystic Ovary SyndromeNCT00606671
Metabolic Disturbances in Polycystic Ovary Syndrome (PCOS)
An observational study of Polycystic Ovary Syndrome, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The scope of the study was to investigate different metabolic aspects that may lead to or are a consequence of insulin resistance in premenopausal women with polycystic ovary syndrome (PCOS). We use gold standard methods for evaluation of insulin resistance. Read more about this study
- Who is it for?
- Ages 18 to 38 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
- Feb 2004to May 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 38 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: lean and obese women with and without PCOS
Who may be able to join
- Premenopausal women that meet the Rotterdam criteria for PCOS (BMI < 40)
- Age and BMI matched control women that do not have any signs or symptoms of PCOS
Who cannot join
- BMI > 40. mani fest diabetes or other known diseases
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dpt. of Obstetrics and Gynaecology, Copenhagen University Hospital, Hvidovre
Hvidovre, 2650
About this study
Official title: Insulin Resistance in Polycystic Ovary Syndrome (PCOS)
The scope of the study was to investigate different metabolic aspects that may lead to or are a consequence of insulin resistance in premenopausal women with polycystic ovary syndrome (PCOS). We use gold standard methods for evaluation of insulin resistance. We take muscle and fat biopsies for investigation of gene expression of different cytokines associated with insulin resistance. We investigate the incretin hormones GIP and GLP-1. These two hormones play a central role in glycemic control, and diabetic subjects are known to have alterations in their incretin hormones. The incretin hormones have not previously been investigated in women with PCOS.
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- polycystic ovary syndrome (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 |
|---|---|---|
| 1 | lean control women without PCOS | |
| 2 | lean women with PCOS | |
| 3 | Obese control women without PCOS | |
| 4 | Obese women with PCOS | |
| 1xx - 04 LC | lean control women | |
| 1xx-04 LP | lean women with PCOS | |
| 1xx-04 OC | obese control women | |
| 1xx-04 OP | obese women with PCOS |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin resistance
Measured: 2004-2006
Secondary outcomes (1)
gene expression of cytokines in fatty tissue
Measured: 2004-2006
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2008 (estimated)
- Study startFeb 2004
- Primary completionMay 2006
- Study completionMay 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
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Diabetesforeningen, Danish Hospital foundation for medical research. region Copenhagen, The Faroe Islands and Greenland., Aage Bangs Fond
- Investigators
- Pernille Fog Svendsen, MD, Principal investigator, Dpt. of Obstetrics and Gynaecology, Copenhagen University Hospital, Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00606671
- Sponsor's protocol ID
- PCOS
- Status last verified
- Jan 2008
- First submitted
- 17 Jan 2008
- Last updated
- 4 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Resistance in Polycystic Ovary Syndrome (PCOS)
- ClinicalTrials.gov ID
- NCT00606671
- Acronym / sponsor ID
- PCOS
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- polycystic ovary syndrome (PCOS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Diabetesforeningen, Danish Hospital foundation for medical research. region Copenhagen, The Faroe Islands and Greenland., Aage Bangs Fond
- Study start
- Feb 2004
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 4 Feb 2008 (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 scope of the study was to investigate different metabolic aspects that may lead to or are a consequence of insulin resistance in premenopausal women with polycystic ovary syndrome (PCOS). We use gold standard methods for evaluation of insulin resistance. We take muscle and fat biopsies for investigation of gene expression of different cytokines associated with insulin resistance. We investigate the incretin hormones GIP and GLP-1. These two hormones play a central role in glycemic control, and diabetic subjects are known to have alterations in their incretin hormones. The incretin hormones have not previously been investigated in women with PCOS.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –lean control women without PCOS |
| 2 | – | –lean women with PCOS |
| 3 | – | –Obese control women without PCOS |
| 4 | – | –Obese women with PCOS |
| 1xx - 04 LC | – | –lean control women |
| 1xx-04 LP | – | –lean women with PCOS |
| 1xx-04 OC | – | –obese control women |
| 1xx-04 OP | – | –obese women with PCOS |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- lean and obese women with and without PCOS
Key inclusion criteria (2 listed)
- Premenopausal women that meet the Rotterdam criteria for PCOS (BMI < 40)
- Age and BMI matched control women that do not have any signs or symptoms of PCOS
Key exclusion criteria (1 listed)
- BMI > 40. mani fest diabetes or 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
insulin resistance
Time frame: 2004-2006
1 secondary outcome
gene expression of cytokines in fatty tissue
Time frame: 2004-2006
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 4 Feb 2008.
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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
Dpt. of Obstetrics and Gynaecology, 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 Hvidovre University Hospital 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 2 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 4 Feb 2008. 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?
insulin resistance (time frame: 2004-2006). 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 4 Feb 2008.