Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01859663
Recruitment Status : Suspended (Suspended due to COVID-19; no suspension of IRB approval.)
First Posted : May 22, 2013
Last Update Posted : April 17, 2020
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, 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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 360 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 : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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).
Women with a history of irregular menstrual cycles
We aim to recruit 120 women with a history of irregular menstrual cycles, and no previous 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).



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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 48 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
New York State. Must be between 18-48 years, with a BMI of 18 kg/m2 or higher.
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

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


Locations
Layout table for location information
United States, New York
Human Metabolic Research Unit, Cornell University
Ithaca, New York, United States, 14853
Strong Fertility Center
Rochester, New York, United States, 14623
CRC at University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
Cornell University
University of Rochester
Investigators
Layout table for investigator information
Principal Investigator: Marla E. Lujan, PhD Cornell University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Cornell University
ClinicalTrials.gov Identifier: NCT01859663    
Other Study ID Numbers: IRB 1303003665
First Posted: May 22, 2013    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 2020
Keywords provided by Cornell University:
Polycystic Ovary Syndrome (PCOS)
Diet
Exercise
Questionnaires
Health Beliefs
Additional relevant MeSH terms:
Layout table for 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