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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01463969
Other study ID # 23.10.2011
Secondary ID 24.05.2011
Status Completed
Phase N/A
First received October 23, 2011
Last updated November 1, 2011
Start date May 2010
Est. completion date May 2011

Study information

Verified date October 2011
Source Gulhane School of Medicine
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date May 2011
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Gulhane School of Medicine Ankara
Turkey Gulhane School of Medicine Dep. of Endocrine and Metabolism Ankara
Turkey Gulhane School of Medicine Dep. of Endocrinology and Metabolism Ankara

Sponsors (1)

Lead Sponsor Collaborator
Gulhane School of Medicine

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Level of of pentraxin3 in cases with Polycystic Ovarian Syndrome Mean PTX3 was significantly higher in patients with PCOS. This means that there is increased level of inflamation in patients with PCOS. 1 year Yes
Secondary Relationship of PTX3 with insuline resistance in patients with PCOS. PTX3 was positively correlated with HOMA-IR. This means that inflamation may cause insuline resistance in patients with PCOS. 1 year Yes
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