Clinical trial NCT02903797: Irisin Hormone Levels in Endometrial Hyperplasia
Official title: The Relation Between Serum Irisin Hormone Level and Endometrial Hyperplasia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometrial Hyperplasia
Keywords: Endometrial hyperplasia
Irisin
fibronectin type III domain containing 5
FNDC5 (fibronectin type III domain containing )
Lead sponsor: Kayseri Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2016-09-16
Enrollment: 80
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Serum irisin hormone levels in endometrial hyperplasia
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Kayseri Training and Research Hospital
Study officials:
affiliation: Kayseri Training and Research Hospital
name: Erdem SAHİN
role: PRINCIPAL_INVESTIGATOR
References: