- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01382576
Women With Polycystic Ovary Syndrome Have Increased Plasma Chitotriosidase Activity
March 9, 2012 updated by: Aydogan Aydogdu, Gulhane School of Medicine
Women With Polycystic Ovary Syndrome Have Increased Plasma Chitotriosidase Activity: A Pathophysiological Link Between Inflammation and Impaired Insulin Sensitivity?
In the present study, serum chitotriosidase activity and its relationship with insulin resistance were determined in patients with Polycystic Ovary Syndrome (PCOS).
Study Overview
Status
Completed
Conditions
Detailed Description
ChT activity is increased in patients with PCOS in concordance with insulin resistance.
These findings may reflect the pronounced risk for metabolic syndrome and atherosclerotic diseases in this particular patient group.
Study Type
Observational
Enrollment (Actual)
78
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, 06180
- Gulhane School of Medicine Etlik
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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 35 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
34 women with PCOS and 44 healty women as control group.
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
- ovarian tumors
- congenital adrenal hyperplasia or BMI greater than 30 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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PCOS patients
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PCOS patients and healthy controls
There are two groups in this study.
One group is PCOS patients and other group is healthy controls.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Aydogan Aydogdu, MD, No organizational affiliation
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
January 1, 2010
Primary Completion (ACTUAL)
December 1, 2010
Study Completion (ACTUAL)
December 1, 2010
Study Registration Dates
First Submitted
June 10, 2011
First Submitted That Met QC Criteria
June 24, 2011
First Posted (ESTIMATE)
June 27, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
March 12, 2012
Last Update Submitted That Met QC Criteria
March 9, 2012
Last Verified
December 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1491-81-11/1539-1563
- Chitotriosidase activity (OTHER_GRANT: 1202-0811)
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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