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

NCT07739953 | Active Not Recruiting

• 1 other identifier: GuangdongWCH-Li Li4
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (1)

• adverse pregnancy outcomes and long-term complications such as type 2 diabetes mellitus

  1year

Interventions

observational study OTHER

Observational Study

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may not qualify if:

• PCOS with Insulin Resistance (PCOS-IR)
• 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).
• Other endocrine disorders; Medication effects; Severe systemic diseases; Special physiological conditions (e.g., pregnancy, lactation); Poor sample quality.
• PCOS without Insulin Resistance (PCOS-non-IR)
• Meets the PCOS diagnostic criteria (as above), with HOMA-IR \< 2.5 and no glucose metabolism abnormalities.

Sponsors & Collaborators

• Guangdong Women and Children Hospital: lead

Study Sites (1)

Guangdong Women and Children Hospital

Guangzhou, China

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Observation

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: July 31, 2026
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)