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

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ClinicalTrials.gov Identifier: NCT01859663
Recruitment Status : Recruiting
First Posted : May 22, 2013
Last Update Posted : February 22, 2018
Sponsor:
Collaborator:
University of Rochester
Information provided by (Responsible Party):
Cornell University

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.

Condition or disease
Polycystic Ovary Syndrome Dietary Habits Physical Activity

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, 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.


Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Baseline Assessment of Dietary Intake and Physical Activity in Women With Polycystic Ovary Syndrome (PCOS)
Study Start Date : May 2013
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
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).



Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Whole blood and urine samples. Subcutaneous fat biopsy.


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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
New York State. Must be between 18-38 years, with a BMI of 18 kg/m2 or higher.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01859663


Contacts
Contact: Marla E. Lujan, PhD 607-255-3153 MEL245@cornell.edu
Contact: Annie Lin, PhD, RD 607-255-5983 AL864@cornell.edu

Locations
United States, New York
Human Metabolic Research Unit, Cornell University Recruiting
Ithaca, New York, United States, 14853
Contact: Erica Bender, MSN, CNM    607-255-9417    eb572@cornell.edu   
Principal Investigator: Marla E. Lujan, PhD         
Strong Fertility Center Recruiting
Rochester, New York, United States, 14623
Contact: Lynda Kochman, RN, CCRC    585-273-2995    Lynda_kochman@urmc.rochester.edu   
CRC at University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Kathleen Hoeger, MD, MPH         
Sponsors and Collaborators
Cornell University
University of Rochester
Investigators
Principal Investigator: Marla E. Lujan, PhD Cornell University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cornell University
ClinicalTrials.gov Identifier: NCT01859663     History of Changes
Other Study ID Numbers: IRB 1303003665
First Posted: May 22, 2013    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018

Keywords provided by Cornell University:
Polycystic Ovary Syndrome (PCOS)
Diet
Exercise
Questionnaires
Health Beliefs

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases