Hepassocin Levels in Patients With Polycystic Ovary Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Polycystic Ovary Syndrome; Insulin Resistance; Hepassocin (Hepatocyte-derived Fibrinogen-related Protein 1)
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Gaziosmanpasa Taksim Education and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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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Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hepassocin levels in patients with polycystic ovary syndrome	hepassocin levels should be increased in polycyctic ovary syndrome due to its relation with insulin resistance.	January 2020-March 2020

Collaborators and Investigators

• Sponsor: Fatma ketenci gencer
• Investigators: Study Director: fatma ketenci gencer, Gaziosmanpasa Taksim Education and Research Hospital; Study Chair: sibel bektas, Gaziosmanpasa Taksim Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2020
• Primary Completion (Actual): March 15, 2020
• Study Completion (Actual): March 25, 2020

Study Registration Dates

• First Submitted: April 26, 2020
• First Submitted That Met QC Criteria: April 29, 2020
• First Posted (Actual): April 30, 2020

Study Record Updates

• Last Update Posted (Actual): April 30, 2020
• Last Update Submitted That Met QC Criteria: April 29, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Hyperinsulinism; Polycystic Ovary Syndrome; Syndrome; Insulin Resistance
• Other Study ID Numbers: GaziosmanpasaTREH19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No