A multicentric case-control study on the role of metabolic and microbiological factors in the development of polycystic ovarian syndrome among women of Gujarat
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- The purpose of this research provides an understanding of the role of bile acid metabolite analysis and gut microbiota alteration between PCOS patients and control groups.
研究概览
简要总结
Background: Polycystic ovary syndrome (PCOS) is a highly prevalent infertility disorder characterized by endocrine, ovarian, and metabolic derangements. It is characterized by enlarged and dysfunctional ovaries, elevated androgen levels, insulin resistance, and other symptoms. According to a survey, 84% of Indian women reported having menstrual problems, and of them, 65% reported having irregular periods and expressing concerns about PCOS. The aetiology of PCOS remains enigmatic. Recently gut microbes have garnered attention as an essential player in this disorder, although the underlying mechanism remains scantly explored.
Novelty: Nascent evidence has suggested that the gut microbes-bile axis is the driver of pathogenesis of PCOS in Chinese women, presenting an exciting possibility of microbe-based therapies. However, gut microbes vary with regions; no study has yet examined the gut microbe-bile acid axis in PCOS women with insulin resistance in India, nor has any study identified keystone species that drive PCOS with insulin resistance in Indian women in a large cohort.
**Expected outcome:**The findings will characterise the gut microbiota-bile axis in PCOS with insulin resistance and help develop microbiome-based biomarkers and treatment of PCOS.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •The study involved PCOS-diagnosed and healthy controls from Gujarat clinics who will provide signed consent forms.
- •Females aged 18-40 (Both inclusion) who are confirmed with a PCOS, based on the Rotterdam criteria.
- •Women who are not pregnant or breastfeeding during the study period.
- •Women who have no acute, hormonal, or neoplastic conditions and autoimmune diseases.
- •Recruitment of healthy controls from hospitals, and educational institutions.
- •Note: We will recruit age, diet, & BMI matched control.
- •The same exclusion criteria will apply for the control.
排除标准
- •The study will exclude smokers, alcoholics, non-vegetarians, and tobacco-chewing participants.
- •This study will exclude participants who have used medications affecting insulin sensitivity (including those for blood pressure, steroids, cholesterol, hormonal contraceptives, antipsychotics, and antibiotics/prebiotics/probiotics) within the past 1 month.
结局指标
主要结局
The purpose of this research provides an understanding of the role of bile acid metabolite analysis and gut microbiota alteration between PCOS patients and control groups.
时间窗: 1 Year
次要结局
- Assessment and understanding the association of homeostasis model assessment for Insulin Resistance (HOMA-IR) scores between lean-obese PCOS patients and the control groups.
- Understand the association of gut microbiota species with bile acid levels (correlation analysis using statistic software).
- Based on the analysis, select potential pathogenic factors contributing to the development of PCOS.
研究者
Ms Foram Ravat
Gujarat Technological University School of Pharmacy