Baseline Assessment of Dietary Intake and Physical Activity in Women With Polycystic Ovary Syndrome (PCOS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 3
- 主要终点
- Differences in diet between women with and without PCOS
研究概览
简要总结
The purpose of the study is to identify lifestyle factors associated with PCOS and understand how diet and activity levels impact features of PCOS. The secondary aim is to examine psychosocial factors (e.g., health beliefs) of women with PCOS.
详细描述
Polycystic ovary syndrome (PCOS) is an endocrine disorder that affects 6-12% of reproductive-aged women within the general population. Currently, there is limited knowledge on the current lifestyles of women with PCOS and the psychosocial factors associated with PCOS.
The researchers plan to examine potential lifestyle differences and psychosocial factors between PCOS and healthy women. The Research Team is also interested in the relationships between biological markers and lifestyle endpoints in women with and without PCOS. Previous literature has shown there are biological marker differences between those with and without PCOS. By examining these relationships, researchers may further understand whether PCOS status is associated with lifestyle parameters.
To accomplish these objectives, 360 women (120 women with PCOS, 120 women without PCOS and with normal menstrual cycles, and 120 women without PCOS and with irregular menstrual cycles) will be included in this study. An equal number of lean and overweight/obese women will be recruited within each group based on body mass index (BMI; Lean = 18 - 24 kg/m2 and overweight/obese ≥ 25 kg/m2). Women will be included in the PCOS group if they have a confirmed PCOS diagnosis from their primary care provider. Participants will complete a food frequency questionnaire, a sleep questionnaire, and a physical activity questionnaire. A researcher may also provide participants with a waist-worn accelerometer to monitor physical activity and a wrist-worn accelerometer to monitor sleep for a week. Ultrasound scans of the ovaries will be assessed and the following metabolic parameters will be assessed: (1) 75-gram oral glucose tolerance test; (2) dual X-ray absorptiometry (DXA) scan; (3) vitals and anthropometry assessment to measure waist and hip circumference, height, weight, blood pressure, and heart rate; (4) fasting blood tests to detect androgens (i.e., total testosterone, androstenedione, free androgen index); and (5) an (optional) subcutaneous fat biopsy. Women with and without PCOS will also be asked to complete a questionnaire that will assess the psychosocial factors (e.g., health beliefs). This can be conducted online, in person, or through phone.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Between 18 and 48 years
- •BMI ≥ 18 kg/m2
- •If ≥ 21 years old, must have completed a pelvic exam in the past 2 years
- •In PCOS if: Confirmed PCOS diagnosis from their primary care provider
排除标准
- •Use of oral contraceptives, fertility medications, or any drugs known to influence reproductive function
- •Pregnant or breastfeeding
结局指标
主要结局
Differences in diet between women with and without PCOS
时间窗: 1 week
A food frequency questionnaire will be administered to assess diet composition for the last three months.
次要结局
- Body fat distribution(1 day)
- Menstrual Cycle Length(1 day)
- Body Mass Index(1 day)
- Waist-to-Hip Ratio(1 day)
- Ovarian Volume(1 day)
- Differences in sleep patterns between women with and without PCOS(6 consecutive nights)
- Differences in exercise between women with and without PCOS(1 week)
- Differences in psychosocial factors (e.g., health beliefs) of women with and without PCOS(1-2 weeks)
- Insulin Sensitivity(1 day)
- Serum progesterone concentration(1 day)
- Blood pressure(1 day)
- LH-FSH ratio(1 day)
- Hirsutism Score(1 day)
- Androgen concentrations(1 day)
- Subcutaneous fat biopsy (optional)(1 day)
- Serum markers of metabolic syndrome(1 day)