Development of Biomarkers for Monitoring Menopause in Women

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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.

Eligibility

Primary outcome measure(s)

• Mitochondrial Quantitative Analysis — 12 months from study start
  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.
• Mitochondrial Qualitative Analysis — 12 months from study start
  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
• Validation of Candidate Biomarkers — 12 months from study start
  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.

Trial sites (1)

More Fu Jen Catholic University Hospital trials in Taiwan