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Completed

NCT Number: NCT01859663

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

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.

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Key information

Age range

18 year–48 year

Sex eligibility

Female

Study type

Observational

Primary location

Human Metabolic Research Unit, Cornell University, Ithaca, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Differences in diet between women with and without PCOS

    Time frame: 1 week

    A food frequency questionnaire will be administered to assess diet composition for the last three months.

Secondary outcomes

  1. Differences in exercise between women with and without PCOS

    Time frame: 1 week

    An accelerometer will be administered to assess physical activity for 1 week.

  2. Differences in psychosocial factors (e.g., health beliefs) of women with and without PCOS

    Time frame: 1-2 weeks

    A questionnaire will be administered to assess psychosocial factors of women with PCOS.

  3. Differences in sleep patterns between women with and without PCOS

    Time frame: 6 consecutive nights

    A wrist-worn accelerometer will be administered to assess sleep patterns for 6 consecutive nights.

  4. LH-FSH ratio

    Time frame: 1 day

    The ratio of circulating LH to FSH concentrations in the serum will be determined for each participant and compared across groups

  5. Hirsutism Score

    Time frame: 1 day

    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

  6. Androgen concentrations

    Time frame: 1 day

    Total testosterone, androstenedione and free androgen index concentrations in serum will be determined and compared across groups.

  7. Menstrual Cycle Length

    Time frame: 1 day

    Average menstrual cycle length as determined by self-reported history will be determined and compared across groups

  8. Body Mass Index

    Time frame: 1 day

    The ratio of weight to height will be determined and compared across groups.

  9. Waist-to-Hip Ratio

    Time frame: 1 day

    The ratio of waist circumference to hip circumference will be determined and compared across groups

  10. Ovarian Volume

    Time frame: 1 day

    The size of each ovary will be determined using ultrasonography for each participant during study participation and compared between groups.

  11. Insulin Sensitivity

    Time frame: 1 day

    Insulin sensitivity will be determined by administration of an oral glucose tolerance test and compared between groups.

  12. Serum progesterone concentration

    Time frame: 1 day

    The serum progesterone concentration will be determined during study participation, assessed in association with luteal dynamics and compared between groups.

  13. Blood pressure

    Time frame: 1 day

    Blood pressure will be determined and compared between groups.

  14. Serum markers of metabolic syndrome

    Time frame: 1 day

    Lipids, glucose and HbA1C concentrations will be determined and compared between groups.

  15. Body fat distribution

    Time frame: 1 day

    Percentage and distribution of fat and lean mass as assessed using DXA technology will be compared between groups.

  16. Subcutaneous fat biopsy (optional)

    Time frame: 1 day

    Subcutaneous fat cells, which represent important sites of reproductive hormone synthesis, will be assessed and compared across groups

Sponsors and collaborators

Lead sponsor

Cornell University

Other

Collaborators

  • University of Rochester

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2022
Study completion
2022
First posted
May 22, 2013
Registry last updated
Feb 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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