Endometrial HyperplasiaNCT02903797
Irisin Hormone Levels in Endometrial Hyperplasia
An observational study of Endometrial Hyperplasia, run by Kayseri Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of the study is to determine serum irisin hormone levels an its relation between endometrial hyperplasia Read more about this study
- Who is it for?
- Ages 35 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Hyperplasia
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2016to Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- between 35-50 years of age
- İn endometrial hyperplasia group; patients who were diagnosed endometrial hyperplasia histopathologically
Who cannot join
- Pregnancy
- Liver function disorders
- Cardiovascular disease
- Metabolic disease
- Diabetes
- Chronic kidney disease
Show all 10Show fewer
- Central nerves system disease
- Immunosuppressive drug use
- Another known malignancy
- Excessive exercises in among one month
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kayseri Training and Research Hospital
Kayseri, 38000
About this study
Official title: The Relation Between Serum Irisin Hormone Level and Endometrial Hyperplasia
The purpose of the study is to determine serum irisin hormone levels an its relation between endometrial hyperplasia
Read the 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.
- Conditions
- Endometrial Hyperplasia
- Keywords
- Endometrial hyperplasia, Irisin, fibronectin type III domain containing 5, FNDC5 (fibronectin type III domain containing )
- Medical subject headings
- Endometrial Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum irisin hormone levels in endometrial hyperplasia
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionJan 2017 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kayseri Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Erdem Sahin, Kayseri Education and Research Hospital
- Investigators
- Erdem SAHİN, Principal investigator, Kayseri Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02903797
- Sponsor's protocol ID
- 2016/466
- Status last verified
- Sep 2016
- First submitted
- 13 Sep 2016
- Last updated
- 16 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relation Between Serum Irisin Hormone Level and Endometrial Hyperplasia
- ClinicalTrials.gov ID
- NCT02903797
- Acronym / sponsor ID
- 2016/466
- Conditions
- Endometrial Hyperplasia
- Keywords
- Endometrial hyperplasia, Irisin, fibronectin type III domain containing 5, FNDC5 (fibronectin type III domain containing )
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kayseri Education and Research HospitalOther government
- Study start
- Aug 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 16 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- between 35-50 years of age
- İn endometrial hyperplasia group; patients who were diagnosed endometrial hyperplasia histopathologically
Key exclusion criteria (10 listed)
- Pregnancy
- Liver function disorders
- Cardiovascular disease
- Metabolic disease
- Diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum irisin hormone levels in endometrial hyperplasia
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erdem SAHİN principal investigator
Kayseri Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Hyperplasia, run by Kayseri Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erdem SAHİN, Principal İnvestigator (+905321688683, erdemsahin07@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum irisin hormone levels in endometrial hyperplasia (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2016; AzTrials last refreshed its copy on 31 Oct 2026.