Development of Biomarkers for Monitoring Menopause in Women

NCT06852755 | Recruiting

• 1 other identifier: FJUH112331
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This cross-sectional study aims to develop and validate mitochondrial biomarkers for monitoring menopause in women. The study will involve 100 participants divided into three groups: reproductive period, perimenopausal transition period, and postmenopausal period. Peripheral blood samples will be collected, and mitochondrial quality and quantity will be assessed using both qualitative and quantitative analyses. The study will identify potential biomarkers through metabolomics and validate them for monitoring the perimenopausal transition, providing a novel approach for women's health management during menopause.

Conditions

Perimenopausal Biomarkers; Mitochondrial Biomarkers

Keywords

Perimenopausal Transition; Mitochondria; Biomarker; Women's Health

Outcome Measures

Primary Outcomes (3)

• Mitochondrial Quantitative Analysis

  This outcome measure involves evaluating mitochondrial energy metabolism, including ATP content, oxygen consumption rate (OCR), and extracellular acidification rate (ECAR) using a hippocampal metabolic analyzer. Additionally, mitochondrial membrane potential will be assessed using flow cytometry to analyze the distribution of JC-1, indicating mitochondrial health. Digital PCR will be employed to measure mitochondrial DNA copy numbers, determining mitochondrial mass and comparing differences between groups.

  12 months from study start

• Mitochondrial Qualitative Analysis

  This measure assesses mitochondrial protein markers using Western blot analysis. PCNA will be used as a nuclear protein marker, while cytochrome c and HSP60 will be used as mitochondrial protein markers to evaluate mitochondrial quality

  12 months from study start

• Validation of Candidate Biomarkers

  This outcome measure focuses on the validation of high-confidence protein markers identified through RNA-Seq and LC-MS/MS data. The validation will be conducted using customized protein databases and further experiments to confirm the feasibility of these candidate biomarkers for monitoring perimenopausal transition.

  12 months from study start

Study Arms (3)

Reproductive Period

Women aged 20-40 years with regular menstrual cycles, representing the reproductive stage.

Other: Blood Sample Collection

Perimenopausal Transition Period

Women aged 40-55 years have menstrual cycle within one year but experiencing menstrual irregularities, representing the transition into menopause.

Other: Blood Sample Collection

Postmenopausal Period

Women aged 50 years and older who have not had a menstrual period for at least one year, representing the postmenopausal stage.

Other: Blood Sample Collection

Interventions

Blood Sample Collection OTHER

Collection of peripheral blood samples for mitochondrial analysis, including the extraction of mononuclear cells and plasma for further assessment of mitochondrial quality and quantity.

Perimenopausal Transition Period; Postmenopausal Period; Reproductive Period

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study Population Description: The study population consists of adult women aged over 20 years old, categorized into three groups: reproductive period (ages 20-45, regular menstrual cycles) perimenopausal transition period (ages 45-50, experiencing menstrual irregularities) postmenopausal period (ages over 50, no menstrual period for at least one year). All participants must be in general good health, without major chronic diseases, infection, or pregnancy.

You may qualify if:

• Biological female, age order than 20 years old.

You may not qualify if:

• Person with cancer.
• Person with any known acute or chronic infection.
• Person with known chronic illness under follow up or treatment.
• Pregnancy, one year withing delivery, under breast feeding, or three months within breast feeding.
• Under any female horemone therapy.

Sponsors & Collaborators

• Fu Jen Catholic University Hospital: lead

Study Sites (1)

Fu Jen Catholic University Hospital, Fu Jen Catholic University

New Taipei City, 24352, Taiwan

RECRUITING

Related Publications (4)

• Davis SR, Lambrinoudaki I, Lumsden M, Mishra GD, Pal L, Rees M, Santoro N, Simoncini T. Menopause. Nat Rev Dis Primers. 2015 Apr 23;1:15004. doi: 10.1038/nrdp.2015.4.

  PMID: 27188659 BACKGROUND

• Pellegrino A, Tiidus PM, Vandenboom R. Mechanisms of Estrogen Influence on Skeletal Muscle: Mass, Regeneration, and Mitochondrial Function. Sports Med. 2022 Dec;52(12):2853-2869. doi: 10.1007/s40279-022-01733-9. Epub 2022 Jul 30.

  PMID: 35907119 BACKGROUND

• Karppinen JE, Tormakangas T, Kujala UM, Sipila S, Laukkanen J, Aukee P, Kovanen V, Laakkonen EK. Menopause modulates the circulating metabolome: evidence from a prospective cohort study. Eur J Prev Cardiol. 2022 Aug 5;29(10):1448-1459. doi: 10.1093/eurjpc/zwac060.

  PMID: 35930503 BACKGROUND

• Powers MS, Schenkel L, Darley PE, Good WR, Balestra JC, Place VA. Pharmacokinetics and pharmacodynamics of transdermal dosage forms of 17 beta-estradiol: comparison with conventional oral estrogens used for hormone replacement. Am J Obstet Gynecol. 1985 Aug 15;152(8):1099-106. doi: 10.1016/0002-9378(85)90569-1.

  PMID: 2992279 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

BLood, will use for checking female hormone (FSH, LH, estrogen, progesterone) and evaluate biomarker from the mitochondria.

Central Study Contacts

Shu-Yu Liu

CONTACT

+886910893512; syliu0123@outlook.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 28, 2025
• Study Start: July 30, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)