Comparison of Lifestyle Markers Between Women With and Without Polycystic Ovary Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Baseline Assessment of Dietary Intake and Physical Activity in Women With Polycystic Ovary Syndrome (PCOS)

Conditions
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Polycystic Ovary Syndrome, Dietary Habits, Physical Activity

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Use of oral contraceptives, fertility medications, or any drugs known to influence reproductive function Pregnant or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 48 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women with a past diagnosis of PCOS<br>We aim to recruit 120 women with a past diagnosis of PCOS. An equal number of lean and overweight/obese women will be recruited within this group based on body mass index (BMI; Lean = 18 - 24 kg/m2 and overweight/obese ≥ 25 kg/m2). | |
| Women with a history of regular menstrual cycles<br>We aim to recruit 120 women with a history of regular menstrual cycles. An equal number of lean and overweight/obese women will be recruited within this group based on body mass index (BMI; Lean = 18 - 24 kg/m2 and overweight/obese ≥ 25 kg/m2). | |
| Women with a history of irregular menstrual cycles<br>We aim to recruit 120 women with a history of irregular menstrual cycles, and no previous diagnosis of PCOS. An equal number of lean and overweight/obese women will be recruited within this group based on body mass index (BMI; Lean = 18 - 24 kg/m2 and overweight/obese ≥ 25 kg/m2). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in diet between women with and without PCOS | A food frequency questionnaire will be administered to assess diet composition for the last three months. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in exercise between women with and without PCOS | An accelerometer will be administered to assess physical activity for 1 week. | 1 week | 
| Differences in psychosocial factors (e.g., health beliefs) of women with and without PCOS | A questionnaire will be administered to assess psychosocial factors of women with PCOS. | 1-2 weeks | 
| Differences in sleep patterns between women with and without PCOS | A wrist-worn accelerometer will be administered to assess sleep patterns for 6 consecutive nights. | 6 consecutive nights | 
| LH-FSH ratio | The ratio of circulating LH to FSH concentrations in the serum will be determined for each participant and compared across groups | 1 day | 
| Hirsutism Score | Degree of hirsutism as judged by the Ferriman-Gallwey scale will be determined and compared across groups Degree of hirsutism as judged by the Ferriman-Gallwey scale will be determined and compared across groups | 1 day | 
| Androgen concentrations | Total testosterone, androstenedione and free androgen index concentrations in serum will be determined and compared across groups. | 1 day | 
| Menstrual Cycle Length | Average menstrual cycle length as determined by self-reported history will be determined and compared across groups | 1 day | 
| Body Mass Index | The ratio of weight to height will be determined and compared across groups. | 1 day | 
| Waist-to-Hip Ratio | The ratio of waist circumference to hip circumference will be determined and compared across groups | 1 day | 
| Ovarian Volume | The size of each ovary will be determined using ultrasonography for each participant during study participation and compared between groups. | 1 day | 
| Insulin Sensitivity | Insulin sensitivity will be determined by administration of an oral glucose tolerance test and compared between groups. | 1 day | 
| Serum progesterone concentration | The serum progesterone concentration will be determined during study participation, assessed in association with luteal dynamics and compared between groups. | 1 day | 
| Blood pressure | Blood pressure will be determined and compared between groups. | 1 day | 
| Serum markers of metabolic syndrome | Lipids, glucose and HbA1C concentrations will be determined and compared between groups. | 1 day | 
| Body fat distribution | Percentage and distribution of fat and lean mass as assessed using DXA technology will be compared between groups. | 1 day | 
| Subcutaneous fat biopsy (optional) | Subcutaneous fat cells, which represent important sites of reproductive hormone synthesis, will be assessed and compared across groups | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polycystic Ovary Syndrome (PCOS), Diet, Exercise, Questionnaires, Health Beliefs