Irisin Hormone Levels in Endometrial Hyperplasia

Endometrial Hyperplasia Clinical Trial

Official title:

The Relation Between Serum Irisin Hormone Level and Endometrial Hyperplasia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02903797
• Other study ID #: 2016/466
• Status: Recruiting
• Phase: N/A
• First received: September 13, 2016
• Last updated: September 13, 2016
• Start date: August 2016
• Est. completion date: February 2017

Study information

• Verified date: September 2016
• Source: Kayseri Education and Research Hospital
• Contact: Erdem SAHIN, Principal Investigator
• Phone: +905321688683
• Email: erdemsahin07[@]hotmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 50 Years

Eligibility

Inclusion Criteria:

• between 35-50 years of age

• In 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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Endometrial Hyperplasia
• Hyperplasia

Locations

Country	Name	City	State
Turkey	Kayseri Training and Research Hospital	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
Kayseri Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum irisin hormone levels in endometrial hyperplasia		6 months	No