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Development and Clinical Application of ApoC3 Protein as a Predictive Biomarker for Insulin Resistance in Polycystic Ovary Syndrome

NCT07739953 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2026-07-31

No results posted yet for this study

Summary

Polycystic Ovary Syndrome (PCOS) is the most common reproductive endocrine disorder causing infertility and miscarriage in women. The insulin resistance state in PCOS patients (PCOS with insulin resistance, PCOS-IR) not only affects their fertility but is also associated with a range of health issues, including type 2 diabetes mellitus, endometrial cancer, and spontaneous abortion during pregnancy. There is an urgent clinical need to explore sensitive serum biomarkers for the diagnosis of insulin resistance in PCOS. Our preliminary studies have demonstrated that apolipoprotein C-III (ApoC3) exhibits diagnostic efficacy for PCOS-IR and is positively correlated with HOMA-IR, for which we were granted a national invention patent in China in 2016. Building on our research foundation in PCOS insulin resistance, we have developed a rapid detection kit for the ApoC3 protein, enabling early screening of insulin resistance in PCOS. Furthermore, point-of-care testing (POCT) products can achieve rapid quantitative detection of biomarkers. This project has recently been funded by the Guangdong Provincial Department of Science and Technology under the 2024 Guangdong-Hong Kong-Macao Greater Bay Area International Innovation Center Construction Initiative (Guangdong-Hong Kong-Macao Joint Innovation Field).

Conditions

  • PCOS (Polycystic Ovary Syndrome)

Interventions

OTHER

observational study

Observational Study

Sponsors & Collaborators

  • Guangdong Women and Children Hospital

    lead OTHER

Eligibility

Min Age
16 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2026-12-31
Completion
2027-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07739953 on ClinicalTrials.gov