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

Study Description

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Design

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Groups and Cohorts

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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).

Outcome Measures

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Eligibility Criteria

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Contacts and Locations

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

More Information

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Cornell University
ClinicalTrials.gov Identifier:	NCT01859663 History of Changes
Other Study ID Numbers:	IRB 1303003665
First Posted:	May 22, 2013
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