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Serum Endocan Levels in Polycystic Ovary Syndrome

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ClinicalTrials.gov Identifier: NCT03019679
Recruitment Status : Completed
First Posted : January 12, 2017
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
İlhan Bahri Delibas, Tokat Gaziosmanpasa University

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
Polycystic Ovary Syndrome

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.

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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 : January 2017
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Serum endocan level and its relationship with Polycystic Ovary Syndrome [ Time Frame: 3 months ]

Biospecimen Retention:   None Retained
serum samples,centrifuged


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
84 women with PCOS and 84 healty women as control group.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03019679


Locations
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Turkey
Gaziosmanpasa University
Tokat, Turkey, 60000
Sponsors and Collaborators
Tokat Gaziosmanpasa University
Investigators
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Principal Investigator: Ilhan B Delibas, M.D. Gaziosmanpasa University Department of Obstetrics and Gynecology
Study Chair: Esra Laloglu, M.D. Erzurum Halk Saglıgı Laboratuvarı

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Responsible Party: İlhan Bahri Delibas, Assistant Professor, Tokat Gaziosmanpasa University
ClinicalTrials.gov Identifier: NCT03019679     History of Changes
Other Study ID Numbers: GaziosmanpasaU
First Posted: January 12, 2017    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases