Development and Clinical Application of ApoC3 Protein as a Predictive Biomarker for Insulin Resistance in Polycystic Ovary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- adverse pregnancy outcomes and long-term complications such as type 2 diabetes mellitus
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
- •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.
结局指标
主要结局
adverse pregnancy outcomes and long-term complications such as type 2 diabetes mellitus
时间窗: 1year
次要结局
未报告次要终点
研究者
Li Li
Chief Physician
Guangdong Women and Children Hospital