Evaluating Oxidative Stress in Menopause

NCT04624386 | Completed

• 1 other identifier: menopausethiol
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause; Oxidative Stress

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Evaluating Oxidative Stress According to Years of Menopause

  2 months

• Evaluating Oxidative Stress According to Menopause Related Osteoporosis

  2 months

Study Arms (2)

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

Premenopausal/Control

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

Other: Thiol disulfide level

Interventions

Thiol disulfide level OTHER

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

Postmenopausal/Study; Premenopausal/Control

Eligibility Criteria

• Age: 30 Years - 75 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

Sisli Hamidiye Etfal Training and Research Hospital

Istanbul, 34371, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Thiol disulfide level in venous blood sample

Study Officials

• Nura Fitnat Topbas Selucki, MD

  Sisli Hamidiye Etfal Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 10, 2020
• Study Start: August 30, 2020
• Primary Completion: October 30, 2020
• Study Completion: November 4, 2020
• Last Updated: December 2, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)