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



Status:Active, not recruiting
Conditions:Ovarian Cancer, Food Studies, Women's Studies
Therapuetic Areas:Oncology, Pharmacology / Toxicology, Reproductive
Healthy:No
Age Range:18 - 38
Updated:7/22/2018
Start Date:May 2013
End Date:December 2018

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

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.

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, 240 women (120 women with PCOS, 120 women without PCOS and
with normal 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.

Inclusion Criteria:

- Between 18 and 38 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
We found this trial at
3
sites
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Rochester, NY
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Ithaca, New York 14853
Principal Investigator: Marla E. Lujan, PhD
Phone: 607-255-9417
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mi
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Ithaca, NY
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Rochester, New York 14623
Phone: 585-273-2995
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mi
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Rochester, NY
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