Hepassocin Levels in Patients With Polycystic Ovary Syndrome

Obesity Clinical Trial

Official title:

Hepassocin Levels in Patients With Polycystic Ovary Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04369248
• Other study ID #: GaziosmanpasaTREH19
• Status: Completed
• Start date: January 3, 2020
• Est. completion date: March 25, 2020

Study information

• Verified date: April 2020
• Source: Gaziosmanpasa Taksim Research and Education Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 25, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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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Related Conditions & MeSH terms

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

Intervention

Other:
• hepassocin
hepassocin levels in polycystic ovary syndrome

Locations

Country	Name	City	State
Turkey	Gaziosmanpasa Taksim Education and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Fatma ketenci gencer

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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