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Serum Endocan Levels in Polycystic Ovary Syndrome

Sponsor
Tokat Gaziosmanpasa University (Other)
Overall Status
Completed
CT.gov ID
NCT03019679
Collaborator
(none)
175
Enrollment
1
Location
3
Duration (Months)
59.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    175 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Serum Endocan Levels in Polycystic Ovary Syndrome: a Possible Marker of Angiogenic Dysfunction
    Study Start Date :
    Jan 1, 2017
    Actual Primary Completion Date :
    Apr 1, 2017
    Actual Study Completion Date :
    Apr 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Study group

    Patients with polycystic ovary syndrome
    Control group

    Patients without polycyctic ovary syndrome

    Outcome Measures

    Primary Outcome Measures

    1. Serum endocan level and its relationship with Polycystic Ovary Syndrome [3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gaziosmanpasa University Tokat Turkey 60000

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    İlhan Bahri Delibas, Assistant Professor, Tokat Gaziosmanpasa University
    ClinicalTrials.gov Identifier:
    NCT03019679
    Other Study ID Numbers:
    • GaziosmanpasaU
    First Posted:
    Jan 12, 2017
    Last Update Posted:
    Feb 1, 2021
    Last Verified:
    Jan 1, 2021
    Additional relevant MeSH terms:
    Polycystic Ovary Syndrome
    Syndrome

    Study Results

    No Results Posted as of Feb 1, 2021