Hepassocin Levels in Patients With Polycystic Ovary Syndrome

Completed

• Conditions: Polycystic Ovary Syndrome; Insulin Resistance; Hepassocin (Hepatocyte-derived Fibrinogen-related Protein 1); Obesity
• Interventions: Other: hepassocin

• Registration Number: NCT04369248
• Lead Sponsor: Fatma ketenci gencer

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.

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 Timeline

• Study Start: 2020-01-03
• Primary Completion: 2020-03-15
• Study Completion: 2020-03-25
• Status Verified: 2020-04
• Study First Submitted: 2020-04-26
• Study First Submitted QC: 2020-04-29
• Last Update Submitted: 2020-04-29
• Study First Posted: 2020-04-30
• Last Update Posted: 2020-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	hepassocin	30 healthy women with BMI \< 30 between 18 and 35 years old
Obese PCOS	hepassocin	Obese group are the women with BMI \> 30 between age of 18 and 35.
Non-obese PCOS	hepassocin	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Gaziosmanpasa Taksim Education and Research Hospital; 🇹🇷 Istanbul, Turkey