Serum Endocan Levels in Polycystic Ovary Syndrome

January 28, 2021 updated by: İlhan Bahri Delibas, Tokat Gaziosmanpasa University

Serum Endocan Levels in Polycystic Ovary Syndrome: a Possible Marker of Angiogenic Dysfunction

In this study the investigators aimed to investigate whether there is a relation between polycystic ovary syndrome and serum endocan levels.

Study Overview

Status

Completed

Conditions

Detailed Description

Polycystic ovary syndrome is a disorder which is associated with insulin resistance, diabetes, obesity, and cardiovascular disease. Endothelial dysfunction, which is known to be an early marker of atherosclerosis, has also been shown to have an association with poycystic ovary syndrome. In this study the investigators aimed to investigate whether there is a relation between polycystic ovary syndrome and serum endocan levels. For this purpose the investigators designed a prospective study including two groups. The diagnosis of polycystic ovary syndrome was made in the presence of ;oligo- and/or anovulation,clinical hyperandrogenism and polycystic ovaries. Clinical hyperandrogenism was defined by the presence of hirsutism , acne, or the presence of androgenic alopecia, body mass index (BMI) was calculated as weight in kilograms divided by the square of height in meters. The two groups are compared considering their serum endocan levels,follicle stimulating hormone (FSH), luteinizing hormone (LH), Dihydroepiandesterone sulphate (DHEAS), total testesterone (TT), estradiol (E2) and thyroid stimulating hormone (TSH), fasting blood glucose, triglyceride, total cholesterol, high density lipoprotein, low density lipoprotein, and C-reactive protein (CRP) levels.

Study Type

Observational

Enrollment (Actual)

175

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

  • Turkey
      • Tokat, Turkey, 60000
        • Gaziosmanpasa University

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 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

84 women with PCOS and 84 healty women as control group.

Description

Inclusion Criteria:

  • 18 to 45 years
  • Patients diagnosed with PCOS according to Rotterdam criteris (for the study group)
  • Patients without PCOS and menstrual irregularities (for the control group)
  • 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
  • Endocrine diseases (Cushing disease, 21-Hydroxylase enzyme deficiency, thyroid dysfunction,hyperprolactinemia,diabetes)
  • Chronic diseases (renal insufficiency, cardiovascular, hepatic disease)
  • Oral contraceptive use, anti-androgenic,glucocorticoid, anti-hypertansive- anti-diabetic drug use
  • Smoking or alcohol use

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Study group
Patients with polycystic ovary syndrome
Control group
Patients without polycyctic ovary syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum endocan level and its relationship with Polycystic Ovary Syndrome
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tokat Gaziosmanpasa University

Investigators

  • Principal Investigator: Ilhan B Delibas, M.D., Gaziosmanpasa University Department of Obstetrics and Gynecology
  • Study Chair: Esra Laloglu, M.D., Erzurum Halk Saglıgı Laboratuvarı

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, 2017

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

January 11, 2017

First Submitted That Met QC Criteria

January 11, 2017

First Posted (Estimate)

January 12, 2017

Study Record Updates

Last Update Posted (Actual)

February 1, 2021

Last Update Submitted That Met QC Criteria

January 28, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GaziosmanpasaU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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