- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01463969
High Plasma Level of Long Pentraxin 3 is Associated With Insulin Resistance in Women With Polycystic Ovary Syndrome (PCOS)
November 1, 2011 updated by: Aydogan Aydogdu, Gulhane School of Medicine
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ankara, Turkey, 06018
- Gulhane School of Medicine Dep. of Endocrine and Metabolism
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Ankara, Turkey, 06018
- Gulhane School of Medicine Dep. of Endocrinology and Metabolism
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Ankara, Turkey, 06018
- Gulhane School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
40 PCOS patients and 40 healty controls
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Pregnant
- Possible ovarian tumors,
- Congenital adrenal hyperplasia or
- BMI greater than 35 kg/m2
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Control group
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PCOS patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relationship of PTX3 with insuline resistance in patients with PCOS.
Time Frame: 1 year
|
PTX3 was positively correlated with HOMA-IR.
This means that inflamation may cause insuline resistance in patients with PCOS.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Aydogan Aydogdu, MD, Gulhane School of Medicine Dep. of Endocrinology and Metabolism
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
October 23, 2011
First Submitted That Met QC Criteria
November 1, 2011
First Posted (Estimate)
November 2, 2011
Study Record Updates
Last Update Posted (Estimate)
November 2, 2011
Last Update Submitted That Met QC Criteria
November 1, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23.10.2011
- 24.05.2011 (Registry Identifier: pcos and PTX3)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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