Evaluating Oxidative Stress in Menopause

Completed

• Conditions: Menopause; Oxidative Stress
• Interventions: Other: Thiol disulfide level

• Registration Number: NCT04624386
• Lead Sponsor: Sisli Hamidiye Etfal Training and Research Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-08-30
• Primary Completion: 2020-10-30
• Status Verified: 2020-11
• Study Completion: 2020-11-04
• Study First Submitted: 2020-11-09
• Study First Submitted QC: 2020-11-09
• Study First Posted: 2020-11-10
• Last Update Submitted: 2020-11-30
• Last Update Posted: 2020-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 77

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Postmenopausal/Study	Thiol disulfide level	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.
Premenopausal/Control	Thiol disulfide level	Healthy women who are still having regular menstruations are included in this group

Primary Outcome Measures

Name	Time	Method
Evaluating Oxidative Stress in Menopause	2 months	Thiol disulfide stress will be evaluated using serum samples from postmenopausal women and comparing these results with samples obtained from premenopausal women.

Secondary Outcome Measures

Name	Time	Method
Evaluating Oxidative Stress According to Years of Menopause	2 months	Thiol disulfide levels will be determined and analysis will be done according to the years of menopause
Evaluating Oxidative Stress According to Menopause Related Osteoporosis	2 months	Thiol disulfide levels will be determined and analysis will be done according to the osteoporosis scores evaluated with dxa

Trial Locations

Locations (1)

Sisli Hamidiye Etfal Training and Research Hospital; 🇹🇷 Istanbul, Turkey