Clinical trial NCT03019679: Serum Endocan Levels in Polycystic Ovary Syndrome
Official title: Serum Endocan Levels in Polycystic Ovary Syndrome: a Possible Marker of Angiogenic Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2017-01-12
Enrollment: 175
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 84 women with PCOS and 84 healty women as control group.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Serum endocan level and its relationship with Polycystic Ovary Syndrome
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Gaziosmanpasa University
Study officials:
affiliation: Gaziosmanpasa University Department of Obstetrics and Gynecology
name: Ilhan B Delibas, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Erzurum Halk Saglıgı Laboratuvarı
name: Esra Laloglu, M.D.
role: STUDY_CHAIR
References: