Evaluating Oxidative Stress in Menopause

Evaluating Oxidative Stress in Postmenopausal Women

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.

Study Overview

• Status: Completed
• Conditions: Menopause; Oxidative Stress
• Intervention / Treatment: Other: Thiol disulfide level

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 Type: Observational
• Enrollment (Actual): 77

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34371
    • Şişli Hamidiye Etfal Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Women within 30-75 years of age were recruited to this study. Premenapusal healthy women who visited the clinic for routine gynecological control were included in the control group. Postmenopausal women older than 45 years of age who entered menopause as a natural process were included in the study group.

A total of 43 subjects were included in the study group and 34 subjects were included in the control group

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: 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.
Premenopausal/Control; Healthy women who are still having regular menstruations are included in this group	Other: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sisli Hamidiye Etfal Training and Research Hospital
• Investigators: Principal Investigator: Nura Fitnat Topbas Selucki, MD, Şişli Hamidiye Etfal Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2020
• Primary Completion (Actual): October 30, 2020
• Study Completion (Actual): November 4, 2020

Study Registration Dates

• First Submitted: November 9, 2020
• First Submitted That Met QC Criteria: November 9, 2020
• First Posted (Actual): November 10, 2020

Study Record Updates

• Last Update Posted (Actual): December 2, 2020
• Last Update Submitted That Met QC Criteria: November 30, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: menopausethiol

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No