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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03019679
Other study ID # GaziosmanpasaU
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2017
Est. completion date April 2017

Study information

Verified date January 2021
Source Tokat Gaziosmanpasa University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 175
Est. completion date April 2017
Est. primary completion date April 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Gaziosmanpasa University Tokat

Sponsors (1)

Lead Sponsor Collaborator
Tokat Gaziosmanpasa University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Serum endocan level and its relationship with Polycystic Ovary Syndrome 3 months
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