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 : January 24, 2018
|Condition or disease|
|Polycystic Ovary Syndrome Dietary Habits Physical Activity|
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, 80 women (40 women with PCOS, 40 women without PCOS) will be included in this study. 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 and physical activity questionnaire. A researcher may also provide participants with an accelerometer to wear 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, and (4) fasting blood tests to detect androgens (i.e., total testosterone, androstenedione, free androgen index). 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 :||80 participants|
|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|
- 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.
- 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.
- 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.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01859663
|Contact: Marla E. Lujan, PhD||607-255-3153||MEL245@cornell.edu|
|Contact: Annie Lin, PhD, RD||607-255-5983||AL864@cornell.edu|
|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 firstname.lastname@example.org|
|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|
|Principal Investigator:||Marla E. Lujan, PhD||Cornell University|