Clinical trial NCT01859663: Comparison of Lifestyle Markers Between Women With and Without Polycystic Ovary Syndrome
Official title: Baseline Assessment of Dietary Intake and Physical Activity in Women With Polycystic Ovary Syndrome (PCOS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Dietary Habits
Physical Activity
Keywords: Polycystic Ovary Syndrome (PCOS)
Diet
Exercise
Questionnaires
Health Beliefs
Lead sponsor: Cornell University
Sponsor class: OTHER
Collaborators: name: University of Rochester
First posted: 2013-05-22
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: New York State. Must be between 18-48 years, with a BMI of 18 kg/m2 or higher.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Differences in diet between women with and without PCOS
timeFrame: 1 week
Secondary outcomes:
measure: Differences in exercise between women with and without PCOS
timeFrame: 1 week
measure: Differences in psychosocial factors (e.g., health beliefs) of women with and without PCOS
timeFrame: 1-2 weeks
measure: Differences in sleep patterns between women with and without PCOS
timeFrame: 6 consecutive nights
measure: LH-FSH ratio
timeFrame: 1 day
measure: Hirsutism Score
timeFrame: 1 day
measure: Androgen concentrations
timeFrame: 1 day
measure: Menstrual Cycle Length
timeFrame: 1 day
measure: Body Mass Index
timeFrame: 1 day
measure: Waist-to-Hip Ratio
timeFrame: 1 day
measure: Ovarian Volume
timeFrame: 1 day
measure: Insulin Sensitivity
timeFrame: 1 day
measure: Serum progesterone concentration
timeFrame: 1 day
measure: Blood pressure
timeFrame: 1 day
measure: Serum markers of metabolic syndrome
timeFrame: 1 day
measure: Body fat distribution
timeFrame: 1 day
measure: Subcutaneous fat biopsy (optional)
timeFrame: 1 day
Other outcomes:
Locations:
city: Ithaca
country: United States
facility: Human Metabolic Research Unit, Cornell University
state: New York
city: Rochester
country: United States
facility: Strong Fertility Center
state: New York
city: Rochester
country: United States
facility: CRC at University of Rochester Medical Center
state: New York
Study officials:
affiliation: Cornell University
name: Marla E. Lujan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lin AW, Dollahite JS, Sobal J, Lujan ME. Health-related knowledge, beliefs and self-efficacy in women with polycystic ovary syndrome. Hum Reprod. 2018 Jan 1;33(1):91-100. doi: 10.1093/humrep/dex351.