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Irisin Hormone Levels in Endometrial Hyperplasia

Sponsor
Kayseri Education and Research Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02903797
Collaborator
(none)
80
Enrollment
1
Location
6
Duration (Months)
13.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to determine serum irisin hormone levels an its relation between endometrial hyperplasia

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The study consisted of two groups. The first group was formed of the patients diagnosed endometrial hyperplasia histopathologically , and the controls were healthy women admitted to the clinic just for annual examination without any complain and symptoms. Patients in the 35-50 age range in both groups were included in the study. The histopathologic diagnosis of patients was established for Kayseri Education and Research Hospital Pathology clinics. Demographic parameters such as age, menopausal status, body mass index (BMI), body weight and known familial cancer story were registered.

    Pregnancy, liver function disorders, cardiovascular disease, metabolic disease, diabetes, chronic kidney disease, central nerves system disease, immunosuppressive drug use, another known malignancy and excessive exercises in among one month were all exclusion criteria for the patients.

    3 cc peripheral venous blood samples were taken in the patients' diagnosed endometrial hyperplasia in the course of evaluation the biopsy results and in controls during their examinations just for only once. Blood samples were centrifuged in 3200 rpm speed for 10 minutes, and stored in -80 'C until the analysis. Blood samples were evaluated on the same day after four mounts for stored first blood sample. Serum Irisin levels were evaluated with enzyme- linked immunosorbent assays kit (Catalog number: K4761-100 Biovision USA) in Kayseri Research and Education Hospital Biochemical Clinics.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    The Relation Between Serum Irisin Hormone Level and Endometrial Hyperplasia
    Study Start Date :
    Aug 1, 2016
    Anticipated Primary Completion Date :
    Jan 1, 2017
    Anticipated Study Completion Date :
    Feb 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Endometrial Hyperplasia

    The first group was formed of the patients diagnosed endometrial hyperplasia histopathologically
    Control group

    The control group was formed of the patients who were healthy women admitted to the clinic just for annual examination without any complain and symptoms

    Outcome Measures

    Primary Outcome Measures

    1. Serum irisin hormone levels in endometrial hyperplasia [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • between 35-50 years of age

    • İn endometrial hyperplasia group; patients who were diagnosed endometrial hyperplasia histopathologically

    Exclusion Criteria:

    • Pregnancy

    • Liver function disorders

    • Cardiovascular disease

    • Metabolic disease

    • Diabetes

    • Chronic kidney disease

    • Central nerves system disease

    • Immunosuppressive drug use

    • Another known malignancy

    • Excessive exercises in among one month

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kayseri Training and Research Hospital Kayseri Turkey 38000

    Sponsors and Collaborators

    • Kayseri Education and Research Hospital

    Investigators

    • Principal Investigator: Erdem SAHİN, Kayseri Training and Research Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Erdem Sahin, Principal Investigator, Kayseri Education and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT02903797
    Other Study ID Numbers:
    • 2016/466
    First Posted:
    Sep 16, 2016
    Last Update Posted:
    Sep 16, 2016
    Last Verified:
    Sep 1, 2016
    Keywords provided by Erdem Sahin, Principal Investigator, Kayseri Education and Research Hospital
    Endometrial hyperplasia
    Irisin
    fibronectin type III domain containing 5
    FNDC5 (fibronectin type III domain containing )
    Additional relevant MeSH terms:
    Endometrial Hyperplasia
    Hyperplasia

    Study Results

    No Results Posted as of Sep 16, 2016