Genetic Aspects of Vaginal Aging

July 11, 2023 updated by: Jacek Szymański, Żelazna Medical Centre, LLC

Epigenetic Profile of Vaginal Epithelial Cells in Postmenopausal Women and as a Result of Local Hormone Therapy, Assessed on the Basis of the Analysis of DNA Methylation Level and Expression of TET 1-3 Genes in Terms of the Aging Process

Life expectancy depends on a number of different factors, of which only about 20-30% are genetically determined. The overwhelming majority are non-genetic determinants. One of the proposed mechanisms explaining this aging phenomenon is related to epigenome variability. Epigenetic regulation is mainly based on cytosine methylation / demethylation in DNA and modification of histone proteins. DNA methylation, unlike modification of histone proteins, is a permanent change, the effects of which can be very distant, and the methylation patterns are fixed during subsequent cell divisions. This type of epigenetic modification plays an important role in a variety of cellular processes, such as differentiation, transformation and aging. The most commonly methylated are cytosines within two nucleotide sequences in DNA called CpG islands. Numerous studies confirm the age-related reduction in methylcitosine (5-mC) levels in both the nuclear and mitochondrial genome of cells in various tissues. The enzymes that catalyze this process belong to the family of methyltransferases (DNMTs). Cytosine methylation appears to be one of the key processes in tissue aging. Depending on the type of tissue and DNA region, there is an increase or decrease in cytosine methylation with age. The main process of both passive and active demethylation is the hydroxymethylation of methylcytosine leading to the formation of hydroxymethylcytosine (5-hmC). This process is of great importance in the regulation of gene expression. Three hydroxylases, TET 1-3 enzymes (ten-eleven translocation), take part in the 5mC hydroxylation process in mammalian cells. The resulting 5-hmC is an important intermediate in the process of DNA demethylation. The significant decrease in the level of CpG island methylation in the genome also seems to be of key importance. So far, the role of 5mC, and thus the activity of TET enzymes in the aging process, has not been clearly defined. Previous studies have shown that it can play an important role in the development and aging of the body. In a woman's life, the consequences of the aging process are most severely manifested during the menopause. The deficiency of sex hormones determines a number of processes also occurring in the lower urinary tract. Estrogens are an essential regulator of the physiological function of the vagina. 40-60% of postmenopausal women complain of atrophic changes in the vaginal epithelium (VVA - vulvovaginal atrophy). Vaginal topical estrogens are currently the "gold standard" in VVA therapy. The molecular mechanism of action of estrogens is based on their activation of the estrogen receptors ER-alpha and ER-beta located in the nuclear envelope of cells in target organs. After the ligand binds to the appropriate receptor, a cascade of signals activating the appropriate chromatin-binding transcription factors is triggered. As a result of this process, the expression of genes involved in the processes of proliferation, differentiation as well as apoptosis changes. Therefore, local administration of estrogens is the most effective in improving the physiological condition of the vaginal mucosa epithelium. The question arises, how do hormonal deficiencies appearing in the menopausal period affect epigenetic changes in the genome and, consequently, the modification of gene expression related to the aging processes of the organism? Does the use of hormone therapy affect the regulation of gene expression through changes in the level of genome methylation? Can the determination of the level of total methylation in vaginal mucosa cells serve as a marker of the advancement of the aging process? Additionally, will the assessment of the degree of demethylation of the genome of vaginal mucosa cells by analyzing the level of expression of genes encoding TET 1-3 enzymes and the total level of 5mC allow characterizing epigenetic changes occurring in menopausal women? Is it possible to identify specific genes whose methylation-dependent expression regulates aging? Obtaining answers to such questions may contribute to understanding the role of the epigenome in the aging process of cells, and opening up new possibilities for the implementation of more effective therapies. It is also crucial that the vaginal epithelium is generally not exposed to known environmental factors influencing the course of aging (e.g. UV radiation), and thus the observed epigenetic changes in vaginal epithelial cells should reflect the impact of hormonal disorders on the molecular mechanism of aging.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Warsaw, Poland, 01-004
        • Centrum Medyczne "ŻELAZNA"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Study population description: Women treated in Urogynecological Unit of St. Sophia Hospital in Warsaw (outpatients and hospitalized) who meet the inclusion criteria.

Description

Inclusion Criteria:

  • informed consent of the patient
  • patient's age> 18 years
  • POP-Q < = II
  • non-smoker
  • without prior vaginal surgery

Exclusion Criteria:

  • refusal to participate in the study
  • POP-Q > II
  • smoking
  • internal diseases (diabetes, disorders of the thyroid gland, obesity, cancer, malnutrition, exhaustion)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Premenopausal women (PREM)
Control group
Postmenopausal women (POSMA)
Test group A : postmenopausal women not treated with topical estrogens
Postmenopausal women (POSMB)
Test group B: postmenopausal women treated with topical estrogens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5-hmC content
Time Frame: 30 days
- 5-hmC content and 5-mC increase in tissues with urogenital atrophy
30 days
TET expressiion
Time Frame: 30 days
- TET expression in tissues with urogenital atrophy
30 days
Changes in the 5-hmC
Time Frame: 30 days
- changes in the 5-hmC content and the 5-mC content in vaginal cells after hormone therapy (topical application of estrogens)
30 days
TET expression change
Time Frame: 30 days
- TET expression change after hormone therapy
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Promoter methylation of specific genes involved in the aging process
Time Frame: 30 days
- Methylome analysis to identify promoter methylation of specific genes involved in the aging process
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2021

Primary Completion (Actual)

June 28, 2023

Study Completion (Actual)

July 10, 2023

Study Registration Dates

First Submitted

February 24, 2022

First Submitted That Met QC Criteria

April 7, 2022

First Posted (Actual)

April 8, 2022

Study Record Updates

Last Update Posted (Actual)

July 12, 2023

Last Update Submitted That Met QC Criteria

July 11, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 1 (Mobile Health and Wellness Program)

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