Comparison of Lifestyle Markers Between Women With and Without Polycystic Ovary Syndrome
Ключови думи
Резюме
Описание
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.
Дати
| Последна проверка: | 03/31/2020 |
| Първо изпратено: | 05/16/2013 |
| Очаквано записване подадено: | 05/19/2013 |
| Първо публикувано: | 05/21/2013 |
| Изпратена последна актуализация: | 04/15/2020 |
| Последна актуализация публикувана: | 04/16/2020 |
| Действителна начална дата на проучването: | 04/30/2013 |
| Приблизителна дата на първично завършване: | 11/30/2020 |
| Очаквана дата на завършване на проучването: | 11/30/2020 |
Състояние или заболяване
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Women with a past diagnosis of PCOS 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 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 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). |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
| Полове, допустими за проучване | Female |
| Метод за вземане на проби | Non-Probability Sample |
| Приема здрави доброволци | Да |
| Критерии | 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 |
Резултат
Първични изходни мерки
1. Differences in diet between women with and without PCOS [1 week]
Вторични изходни мерки
1. Differences in exercise between women with and without PCOS [1 week]
2. Differences in psychosocial factors (e.g., health beliefs) of women with and without PCOS [1-2 weeks]
3. Differences in sleep patterns between women with and without PCOS [6 consecutive nights]
4. LH-FSH ratio [1 day]
5. Hirsutism Score [1 day]
6. Androgen concentrations [1 day]
7. Menstrual Cycle Length [1 day]
8. Body Mass Index [1 day]
9. Waist-to-Hip Ratio [1 day]
10. Ovarian Volume [1 day]
11. Insulin Sensitivity [1 day]
12. Serum progesterone concentration [1 day]
13. Blood pressure [1 day]
14. Serum markers of metabolic syndrome [1 day]
15. Body fat distribution [1 day]
16. Subcutaneous fat biopsy (optional) [1 day]
