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Evaluating Oxidative Stress in Menopause

NCT ID: NCT04624386

Last Updated: 2020-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

77 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-30

Study Completion Date

2020-11-04

Brief Summary

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Thiol disulfide levels will be determined using venous blood samples from pre- and postmenopausal women to evaluate oxidative stress in menopause. Furthermore, oxidative stress will be assessed according to age, and years since the start of menopause. Also, whether the presence of menopause related osteoporosis has any association with oxidative stress will be determined.

Detailed Description

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A total of 77 subjects are divided into two groups: study group (postmenopausal women) and control group premenopausal women). Biometric data such as age, bmi, obstetric anamnesis, history of komorbidities, PAP smear results are recorded. Mammography results, dexa scores of post menopausal women are also obtained. Venous blood samples from all subjects are collected. Thiol disulfide levels will be determined from serum samples. Thiol disulfide levels will first be compared between the study and the control group in order to determine the oxidative stress in menopause. In secondary evaluation years of menopause, age, and dexa scores will be included.

Conditions

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Menopause Oxidative Stress

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Postmenopausal/Study

Women older than 45 years of age and who have not had any menstruation for the past 12 months are considered as having entered menopause. These women are included in this group.

Thiol disulfide level

Intervention Type OTHER

Venous blood is collected from all subjects and thiol disulfide levels will be determined from the serum samples obtained from the venous blood.

Premenopausal/Control

Healthy women who are still having regular menstruations are included in this group

Thiol disulfide level

Intervention Type OTHER

Venous blood is collected from all subjects and thiol disulfide levels will be determined from the serum samples obtained from the venous blood.

Interventions

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Thiol disulfide level

Venous blood is collected from all subjects and thiol disulfide levels will be determined from the serum samples obtained from the venous blood.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Women who entered menopause as a natural process Women within the age limits Still menstruating healthy women as control subjects

Exclusion Criteria

Women who have entered menopause prematurely Women who have entered menopause following a surgery Women with medically induced menopause Women without any autoimmune or chronic inflammatory diseases Women who are taking hormone replacement therapy due to menopausal symptoms Women without any malignant diseases
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sisli Hamidiye Etfal Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nura Fitnat Topbas Selcuki

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nura Fitnat Topbas Selucki, MD

Role: PRINCIPAL_INVESTIGATOR

Sisli Hamidiye Etfal Training and Research Hospital

Locations

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Sisli Hamidiye Etfal Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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menopausethiol

Identifier Type: -

Identifier Source: org_study_id