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.
Polycystic Ovary Syndrome
|Study Design:||Observational Model: Case Control
Time Perspective: Retrospective
|Official Title:||Baseline Assessment of Dietary Intake and Physical Activity in Women With Polycystic Ovary Syndrome (PCOS)|
- Differences in diet composition between women with and without PCOS [ Time Frame: 1 week ] [ Designated as safety issue: No ]A food frequency questionnaire will be administered to assess diet composition for the last three months.
- Differences in energy expenditure between women with and without PCOS [ Time Frame: 1 week ] [ Designated as safety issue: No ]Participants will be asked to wear a small accelerometer device to assess physical activity.
Biospecimen Retention: Samples With DNA
Whole blood and urine samples
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Polycystic ovary syndrome (PCOS) is an endocrine disorder that affects 6-12% of reproductive-aged women within the general population. There has been evidence to suggest women whom present with obesity and/or insulin resistance are at higher risk for developing PCOS. This condition is associated with negative health implications. Women with PCOS women are at increased risk for developing type 2 diabetes, metabolic syndrome and cardiovascular disease compared to age- and weight- matched controls, indicating PCOS may increase an individual's susceptibility for chronic disease.
Current research has failed to thoroughly examine the relationships between dietary intake, energy expenditure and PCOS. The purpose of this proposed study is to identify lifestyle factors associated with PCOS. Through dietary intake and energy expenditure data, the researchers plan to examine potential lifestyle differences between PCOS and healthy women, as well as between BMI classifications within women with PCOS. The Research Team will also be able to evaluate the diet quality according to the USDA Dietary Guidelines for Americans of all women included in the study. 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. Participants will be between 18 and 38 years, with BMI ≥ 18.5 kg/m2 and will not have use of oral contraceptives within the last three months. 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 for the total number and size of follicles using both two- and three-dimensional imaging techniques. Participants will have blood samples collected determine LH, FSH, estrogens, and progesterone levels. The following metabolic parameters will be assessed: (1) 75-gram oral glucose tolerance test to characterize glucose and insulin dynamics at 0, 30, 60, 90, and 120 minutes post-glucose ingestion; (2) dual X-ray absorptiometry (DXA) scan to quantify body fat and lean muscle distribution; (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) and serum markers of metabolic syndrome (i.e., lipids and hemoglobin A1C).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01859663
|Contact: Marla E. Lujan, PhD||607-255-3153||MEL245@cornell.edu|
|Contact: Annie Lin, MS, RD||607-255-5483||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 email@example.com|
|Principal Investigator: Marla E. Lujan, PhD|
|CRC at University of Rochester Medical Center||Recruiting|
|Rochester, New York, United States, 14642|
|Contact: Kathleen Hoeger, PhD|
|Strong Fertility Center||Recruiting|
|Rochester, New York, United States, 14623|
|Contact: Lynda Kochman, RN, CCRC 585-273-2995 Lynda_kochman@urmc.rochester.edu|
|Principal Investigator:||Marla E. Lujan, PhD||Cornell University|