CTRI/2025/08/093056尚未招募不适用
Evaluation of Cardiovascular Health Based on Life’s Essential 8 Metrics in Women with Polycystic Ovary Syndrome(PCOS)
未提供1 个研究点 分布在 1 个国家目标入组 224 人开始时间: 2025年8月25日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- LE 8 metrics score
研究概览
简要总结
| Polycystic Ovarian syndrome (PCOS) is a heterogenous, chronic inflammatory disorder typically characterized by hyperandrogenism, chronic anovulation/oligo-ovulation, and polycystic ovarian morphology with a great deal of variation in symptoms and their severity.Although cardinal symptoms of this disease are menstrual irregularities, acne, hirsutism and infertility, it is associated with a lifetime risk of cardiovascular and metabolic diseases. Emerging data suggests that presence of obesity, insulin resistance and excess androgens predispose these women to an early risk of significant metabolic disturbances like, dyslipidaemia, hypertension and type 2 diabetes mellitus. The International Evidence based PCOS guidelines (2023) has recommended to do universal risk assessment for cardiovascular diseases in PCOS regardless of age and BMI. Much of the management in PCOS is typically focused on addressing current symptoms such as the ovulatory dysfunction and infertility, and not on the long-term risks conferred by PCOS, such as cardiovascular disease (CVD). AHA has published goals and metrics for cardiovascular health and proposed ‘Life’s Essential 8’ (LE8) cardiovascular health metrics to measure, monitor and modify an individual or population’s cardiac health. LE8 metric offers a comprehensive framework to evaluate cardiovascular health by integrating behavioral and clinical factors. Flow-mediated dilation (FMD) and arterial stiffness are non-invasive markers to assess cardiovascular health which reflect endothelial function and arterial elasticity, respectively.In this study we will evaluate the cardiovascular health of women with PCOS using the LE8 metrics .The results of this study will give an insight into the cardiometabolic health of women with PCOS and help us counsel our patients accordingly at diagnosis to prevent such long-term consequences of the syndrome through appropriate lifestyle modifications |
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women diagnosed with PCOS by modified Rotterdam criteria.
排除标准
- •1.Women with endocrine disorders such as Cushing’s Syndrome, acromegaly, pituitary adenoma, hypothyroidism.
- •2.Women with heart, renal or liver diseases.
- •3.Pregnant Women.
结局指标
主要结局
LE 8 metrics score
时间窗: at recruitment
次要结局
- LE 8 metrics
- HOMA -IR
- Arterial Stiffness
- Endothelial Function(at recruitment)
研究者
Dr Garima Kachhawa
All India Institute of Medical Sciences, New Delhi
研究点 (1)
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