Hepassocin Levels in Patients With Polycystic Ovary Syndrome

NCT04369248 | Completed DMC

• 1 other identifier: GaziosmanpasaTREH19
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Control group

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

Other: hepassocin

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

Obese PCOS

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

Other: hepassocin

Interventions

hepassocin OTHER

hepassocin levels in polycystic ovary syndrome

Control group; Non-obese PCOS; Obese PCOS

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fatma ketenci gencer: lead

Study Sites (1)

Gaziosmanpasa Taksim Education and Research Hospital

Istanbul, Turkey (Türkiye)

Location

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.

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Obesity; Insulin Resistance

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• fatma ketenci gencer

  Gaziosmanpasa Taksim Education and Research Hospital

  STUDY DIRECTOR

• sibel bektas

  Gaziosmanpasa Taksim Education and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal invastigator

Study Record Dates

• First Submitted: April 26, 2020
• First Posted: April 30, 2020
• Study Start: January 3, 2020
• Primary Completion: March 15, 2020
• Study Completion: March 25, 2020
• Last Updated: April 30, 2020

Record last verified: 2020-04

Locations

TU (1)