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High Plasma Level of Long Pentraxin 3 is Associated With Insulin Resistance in Women With Polycystic Ovary Syndrome (PCOS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aydogan Aydogdu, Gulhane School of Medicine
ClinicalTrials.gov Identifier:
NCT01463969
First received: October 23, 2011
Last updated: November 1, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition
PCOS

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: High Plasma Level of Long Pentraxin 3 is Associated With Insulin Resistance in Women With Polycystic Ovary Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Gulhane School of Medicine:

Primary Outcome Measures:
  • Level of of pentraxin3 in cases with Polycystic Ovarian Syndrome [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Mean PTX3 was significantly higher in patients with PCOS. This means that there is increased level of inflamation in patients with PCOS.


Secondary Outcome Measures:
  • Relationship of PTX3 with insuline resistance in patients with PCOS. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    PTX3 was positively correlated with HOMA-IR. This means that inflamation may cause insuline resistance in patients with PCOS.


Enrollment: 80
Study Start Date: May 2010
Study Completion Date: May 2011
Groups/Cohorts
PCOS patients
Control group

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

40 PCOS patients and 40 healty controls

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01463969

Locations
Turkey
Gulhane School of Medicine Dep. of Endocrinology and Metabolism
Ankara, Turkey, 06018
Gulhane School of Medicine Dep. of Endocrine and Metabolism
Ankara, Turkey, 06018
Gulhane School of Medicine
Ankara, Turkey, 06018
Sponsors and Collaborators
Gulhane School of Medicine
Investigators
Principal Investigator: Aydogan Aydogdu, MD Gulhane School of Medicine Dep. of Endocrinology and Metabolism
  More Information

No publications provided

Responsible Party: Aydogan Aydogdu, MD, Gulhane School of Medicine
ClinicalTrials.gov Identifier: NCT01463969     History of Changes
Other Study ID Numbers: 23.10.2011, 24.05.2011
Study First Received: October 23, 2011
Last Updated: November 1, 2011
Health Authority: Turkey: Ethics Committee

Keywords provided by Gulhane School of Medicine:
PCOS and PTX3 levels

Additional relevant MeSH terms:
Insulin Resistance
Polycystic Ovary Syndrome
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Ovarian Cysts
Cysts
 Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013