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

  • STATUS
    Recruiting
  • End date
    Dec 27, 2022
  • participants needed
    360
  • sponsor
    Cornell University
Updated on 27 January 2021
pelvic examination

Summary

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.

Description

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.

Details
Condition OVARIAN CYST, Ovarian Cysts, Physical activity, Dietary Modification, Polycystic Ovary Syndrome, Polycystic Ovarian Syndrome, Ovarian Cysts, Polycystic Ovarian Syndrome, pcos, polycystic ovary disease
Clinical Study IdentifierNCT01859663
SponsorCornell University
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

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
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