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Hepassocin Levels in Patients With Polycystic Ovary Syndrome

NCT ID: NCT04369248

Last Updated: 2020-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-03

Study Completion Date

2020-03-25

Brief Summary

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The investigators aimed to investigate hepassocin levels in patients with polycystic ovary syndrome (PCOS). There are 3 groups aged between 18 and 35 years as non-obese healthy women, non-obese women with PCOS, and obese women (BMI\>30) with PCOS.

Detailed Description

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Hepassocin, also known as Fibrinogen-like-protein or hepatocyte-derived fibrinogen-related protein 1, is a new marker for obesity and insulin resistance. In hepatic injury, it protects liver cells and promotes regeneration. High levels of hepassocin was shown to be independently associated with HOMA-IR and diabetes. Since insulin resistance is known to be seen in patients with PCOS, it may be expected that hepassocin levels may be higher in this group of patients.

Conditions

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Hepassocin (Hepatocyte-derived Fibrinogen-related Protein 1) Polycystic Ovary Syndrome Obesity Insulin Resistance

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control group

30 healthy women with BMI \< 30 between 18 and 35 years old

hepassocin

Intervention Type OTHER

hepassocin levels in polycystic ovary syndrome

Non-obese PCOS

2003 Rotterdam ESHRE/ASRM PCOS Consensus Criteria were used to diagnose PCOS that fulfilled at least two of the followings: chronic oligo-anovulation, clinic or biochemical hyperandrogenism and presence of polycyctic ovary by ultrasound (Rotterdam). Oligo-anovulation is defined as periods lasting more than 35 days and/or amenorrhea. Clinic or biochemical hyperandrogenism is defined as the presence of acnes and/ or Ferriman-Galleway modified score \>8 and/ or hyperandrogenemia defining the testosterone level \> 0.6 ng/ml (2 nmol/l) and/or dehydroepiandrosterone level \> 3 ng/ml (10.5 nmol/l). Polycyctic ovaries are defined as the presence of more than 12 follicules 2-9 mm in diameters or ovarian volume \>10 cm3 under transvaginal or abdominal ultrasound. non-obese group are the women BMI \< 30 between age of 18 and 35.

hepassocin

Intervention Type OTHER

hepassocin levels in polycystic ovary syndrome

Obese PCOS

Obese group are the women with BMI \> 30 between age of 18 and 35.

hepassocin

Intervention Type OTHER

hepassocin levels in polycystic ovary syndrome

Interventions

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hepassocin

hepassocin levels in polycystic ovary syndrome

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 60 patients with PCOS aged between 18 and 35 and age-matched 30 healthy women with BMI\<30

Exclusion Criteria

Premature ovarian failure (FSH \>30 mIU/mL), tumors secreting androgens, non-classical congenital adrenal hyperplasia, Cushing syndrome and irregular menses due to thyroid dysfunction (TSH \>5 mIU/L ), hyperprolactinemia, more than twofold high transaminase levels (\>70 U/L), patients with cigarette smoking, alcohol consumption, oral contraceptives use, medications that are affecting liver function test, insulin metabolism and lipid metabolism, patients with a history of chronic diseases such as diabetes mellitus, hypertension, chronic liver disease, chronic kidney disease, autoimmune disease, inflammatory disease, malignant disease, bleeding disorders, and thrombosis were also excluded. All the patients were beta-HCG, hepatitis B surface antigen, and hepatitis C antibody negative.

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Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fatma ketenci gencer

OTHER_GOV

Sponsor Role lead

Responsible Party

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Fatma ketenci gencer

principal invastigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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fatma ketenci gencer

Role: STUDY_DIRECTOR

Gaziosmanpasa Taksim Education and Research Hospital

sibel bektas

Role: STUDY_CHAIR

Gaziosmanpasa Taksim Education and Research Hospital

Locations

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Gaziosmanpasa Taksim Education and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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GaziosmanpasaTREH19

Identifier Type: -

Identifier Source: org_study_id