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Hepassocin Levels in Patients With Polycystic Ovary Syndrome

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ClinicalTrials.gov Identifier: NCT04369248
Recruitment Status : Completed
First Posted : April 30, 2020
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
Fatma ketenci gencer, Gaziosmanpasa Taksim Research and Education Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Hepassocin (Hepatocyte-derived Fibrinogen-related Protein 1) Polycystic Ovary Syndrome Obesity Insulin Resistance Other: hepassocin

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Hepassocin Levels in Patients With Polycystic Ovary Syndrome
Actual Study Start Date : January 3, 2020
Actual Primary Completion Date : March 15, 2020
Actual Study Completion Date : March 25, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Control group
30 healthy women with BMI < 30 between 18 and 35 years old
Other: hepassocin
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.
Other: hepassocin
hepassocin levels in polycystic ovary syndrome

Obese PCOS
Obese group are the women with BMI > 30 between age of 18 and 35.
Other: hepassocin
hepassocin levels in polycystic ovary syndrome




Primary Outcome Measures :
  1. Hepassocin levels in patients with polycystic ovary syndrome [ Time Frame: January 2020-March 2020 ]
    hepassocin levels should be increased in polycyctic ovary syndrome due to its relation with insulin resistance.


Biospecimen Retention:   Samples Without DNA
Early follicular phase day 3 in case of menstruating and random day for amenorrheic patients was chosen for blood sampling after 8 hour of fasting. The blood samples were obtained from the antecubital vein via a vacutainer. Process of samples was achieved within maximum 1 hour and serum sample was stored in -80 for hepassocin work-up after 5 minutes of centrifuge.


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
A total of 60 patients with PCOS aged between 18 and 35 and age matched 30 healthy women with BMI < 30 were enrolled to the study.
Criteria

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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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): NCT04369248


Locations
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Turkey
Gaziosmanpasa Taksim Education and Research Hospital
Istanbul, Turkey
Sponsors and Collaborators
Fatma ketenci gencer
Investigators
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Study Director: fatma ketenci gencer Gaziosmanpasa Taksim Education and Research Hospital
Study Chair: sibel bektas Gaziosmanpasa Taksim Education and Research Hospital
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Responsible Party: Fatma ketenci gencer, principal invastigator, Gaziosmanpasa Taksim Research and Education Hospital
ClinicalTrials.gov Identifier: NCT04369248    
Other Study ID Numbers: GaziosmanpasaTREH19
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Insulin Resistance
Syndrome
Disease
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases