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

July 28, 2026 updated by: Li Li, Guangdong Women and Children Hospital
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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

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

  • China
      • Guangzhou, China
        • Guangdong Women and Children Hospital

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

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

This study included PCOS patients diagnosed according to the 2003 Rotterdam criteria (at least 2 of: oligo/anovulation, clinical/biochemical hyperandrogenism, or polycystic ovaries on ultrasound). Patients were divided into two groups:

PCOS-IR group: met PCOS criteria plus at least one of: HOMA-IR ≥ 2.5, fasting insulin ≥ 15 μIU/mL, or diagnosed IGT/T2DM.

PCOS-non-IR group: met PCOS criteria with HOMA-IR < 2.5 and no glucose metabolism abnormalities.

Exclusion criteria: other endocrine disorders, medication use, severe systemic diseases, pregnancy/lactation, or poor sample quality.

Description

I. Diagnostic Criteria

The 2003 Rotterdam diagnostic criteria for PCOS jointly established by the European Society of Human Reproduction and Embryology (ESHRE) and the American Society for Reproductive Medicine (ASRM):

Clinical and/or biochemical signs of hyperandrogenism; Oligo-ovulation or anovulation; Ultrasound findings: ovarian volume ≥ 10 mL, and/or > 12 follicles with a diameter of 2-9 mm in a single section.

A diagnosis of PCOS can be established when at least two of the following three criteria are met: ovarian dysfunction, hyperandrogenism, and polycystic ovarian morphology on ultrasound.

II. Inclusion and Exclusion Criteria

  1. PCOS with Insulin Resistance (PCOS-IR)

    Inclusion Criteria:

    Meets the 2003 Rotterdam diagnostic criteria for PCOS (at least 2 of the following 3 items):

    ① Oligo-ovulation or anovulation;

    ② Clinical or biochemical signs of hyperandrogenism;

    ③ Polycystic ovaries on ultrasound (unilateral or ovarian volume ≥ 10 mL).

    Insulin resistance (IR), meeting at least 1 of the following 3 criteria:

    ① HOMA-IR ≥ 2.5;

    ② Fasting insulin ≥ 15 μIU/mL;

    ③ Diagnosed impaired glucose tolerance (IGT) or type 2 diabetes mellitus (T2DM).

    Exclusion Criteria:

    Other endocrine disorders; Medication effects; Severe systemic diseases; Special physiological conditions (e.g., pregnancy, lactation); Poor sample quality.

  2. PCOS without Insulin Resistance (PCOS-non-IR)

Inclusion Criteria:

Meets the PCOS diagnostic criteria (as above), with HOMA-IR < 2.5 and no glucose metabolism abnormalities.

Exclusion Criteria: Same as above.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
adverse pregnancy outcomes and long-term complications such as type 2 diabetes mellitus
Time Frame: 1year
1year

Collaborators and Investigators

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

Sponsor

Guangdong Women and Children Hospital

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)

June 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

July 28, 2026

First Submitted That Met QC Criteria

July 28, 2026

First Posted (Actual)

July 31, 2026

Study Record Updates

Last Update Posted (Actual)

July 31, 2026

Last Update Submitted That Met QC Criteria

July 28, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GuangdongWCH-Li Li4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe