PREVALENCE OF METABOLIC SYNDROME AMONG WOMEN WITH POLYCYSTIC OVARY SYNDROME (PCOS): IMPACT OF LIFESTYLE TREATMENT IN THE MANAGEMENT OF REPRODUCTIVE, ANTHROPOMETRIC, METABOLIC AND QUALITY OF LIFE FACTORS IN PCOS
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Homeostasis Model Assessment of Insulin Resistance (HOMA IR 2)
研究概览
简要总结
This randomized controlled trial aims to assess the impact of lifestyle treatment on reproductive, anthropometric, metabolic, and quality of life outcomes in women with Polycystic Ovary Syndrome (PCOS). Participants will be recruited from outpatient facilities of selected hospitals in Vadodara, Gujarat, India. Thirty subjects in the experimental group will receive interpersonal nutritional counseling along with standard care for 60 days, followed by a 60-day washout period, while thirty subjects in the control group will receive only standard care. Data on insulin sensitivity (HOMA-IR), lipid profile, hs-CRP, thyroid profile, reproductive factors (menstrual regularity, ovarian morphology), anthropometric measurements (weight, height, waist circumference, hip circumference, waist-to-hip ratio), psychosocial factors (stress, depression, anxiety), quality of life, and lifestyle factors (physical activity, sleep patterns, diet) will be collected at baseline, after 60 days, and after 120 days. The null hypothesis is that lifestyle treatment may not be effective in improving insulin resistance in PCOS subjects, and the trial will be conducted under the supervision of a gynecologist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 49.00 Year(s)(—)
- 性别
- Female
入选标准
- ••Age – 18 to 49 years •Women with confirmed PCOS (Rotterdam Criteria) •Women who have attained menarche more than 2 years before the study •Women who are willing to participate.
排除标准
- ••Pregnant Women •Known case of thyroid disorder, cushing’s syndrome, hyperprolactinemia, nonclassic adrenal hyperplasia •Women on insulin sensitizers.
结局指标
主要结局
Homeostasis Model Assessment of Insulin Resistance (HOMA IR 2)
时间窗: Baseline: At the beginning of the study | Midpoint: After 2 months of intervention | Follow-up: 2 months after the washout period (4 months from the start of the study)
次要结局
- Metabolic parameters (Lipid profile, thyroid profile, Hs-CRP, FBS) anthropometric, reproductive, and quality of life(Baseline: At the beginning of the study)
研究者
Prof Dr Uma Iyer
The Maharaja Sayajirao University of Baroda
