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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Cornell University
Sponsor:
Collaborator:
University of Rochester
Information provided by (Responsible Party):
Cornell University
ClinicalTrials.gov Identifier:
NCT01859663
First received: May 17, 2013
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

The purpose of the study is to identify lifestyle factors associated with PCOS and understand how diet and activity levels impact features of PCOS.


Condition
Polycystic Ovary Syndrome
Dietary Habits
Physical Activity

Study Type: Observational
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)

Resource links provided by NLM:


Further study details as provided by Cornell University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 80
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)
Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women able to transport to Cornell University and University of Rochester. Must be between 18-38 years, with a BMI of 18.5 kg/m2 or higher.

Criteria

Inclusion Criteria:

  • Between 18 and 38 years
  • BMI ≥ 18.5 kg/m2
  • In PCOS if: Confirmed PCOS diagnosis from their primary care provider

Exclusion Criteria:

  • Use of oral contraceptives
  • Significant weight changes within the last three months
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01859663

Contacts
Contact: Marla E. Lujan, PhD 607-255-3153 MEL245@cornell.edu
Contact: Annie Lin, MS, RD 607-255-5483 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         
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   
Sponsors and Collaborators
Cornell University
University of Rochester
Investigators
Principal Investigator: Marla E. Lujan, PhD Cornell University
  More Information

No publications provided

Responsible Party: Cornell University
ClinicalTrials.gov Identifier: NCT01859663     History of Changes
Other Study ID Numbers: IRB 1303003665
Study First Received: May 17, 2013
Last Updated: July 10, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 27, 2014